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Oct 15Thu
  1. fda.gov53

    FDA Rare Disease Innovation Hub

    The FDA Rare Disease Innovation Hub released its Strategic Agenda on February 2, 2026, setting out its goals and priorities for the coming year for the rare disease community. The Hub, co-led by the directors of CBER, CDER and CDRH with the Oncology Center of Excellence and Office of Orphan Products Development, will focus on products for smaller populations and diseases with variable, poorly understood natural history. It has scheduled public meetings for October 16 and October 28, 2026.

  2. fda.gov46

    Par Health Issues Voluntary Nationwide Recall of Argatroban Injection Due to the Presence of Particulate Matter

    Par Health USA is voluntarily recalling 22 lots of Argatroban Injection 250 mg/2.5 mL (100 mg/mL) to the hospital/user level after particulate matter identified as cellulose, polystyrene, polyethylene terephthalate, stopper material and possibly stainless steel was detected. The affected lots, distributed nationwide to wholesalers and hospitals between December 30, 2024 and May 5, 2026, carry a risk of pulmonary emboli, blood vessel occlusion and vein wall inflammation. No adverse events have been reported; distributors and hospital pharmacies should stop use and return inventory through Inmar, Inc.

  3. fda.gov51

    FDA Rare Disease Framework Initiative Public Meeting - 10/28/2026

    The FDA, with the Reagan-Udall Foundation for the FDA, will hold a hybrid public meeting on October 28, 2026, from 1:00 p.m. to 5:00 p.m. ET at the FDA White Oak Campus in Silver Spring, Maryland, and via Zoom. The meeting seeks input from patients, advocates, sponsors and others on the FDA's Rare Disease Framework Initiative, which aims to build a fit-for-purpose approach to rare disease drug development in small patient populations. Public remarks will inform the agency's work on the Framework, with input sought on fit-for-purpose review, regulatory predictability, external engagement and CMC considerations.

  4. fda.gov62

    FDA Launches the Rare Disease Framework Initiative to Develop a Holistic, Fit-For-Purpose Framework for Rare Disease Drug Development

    The FDA launched the Rare Disease Framework Initiative to build a fit-for-purpose framework for developing drugs and biologics for rare diseases, outlined in a new white paper dated October 14, 2026. The initiative, led by the Rare Disease Innovation Hub with the Commissioner's office, CBER and CDER, will tailor regulatory requirements to small patient populations, with only about 5% of rare conditions having an FDA-approved treatment. A public meeting on October 28 at the White Oak campus, facilitated by the Reagan-Udall Foundation, opens a feedback process that will inform new guidance, regulation revisions, training and organizational changes.

  5. fda.gov63

    Rare Disease Framework

    The FDA, with the Reagan-Udall Foundation for the FDA, will hold a hybrid public meeting on October 28, 2026, to gather input on its Rare Disease Framework Initiative, which aims to reimagine the agency's approach to rare disease drug development and review. The framework would tailor regulatory advice and decision-making to the evidence reasonably attainable for each disease, embed the patient voice at defined milestones, leverage external expertise, and apply risk-based approaches to manufacturing review and inspections. Changes could come through regulations, guidance documents and internal processes; FDA set out its aims in a white paper released October 14, 2026.

    Why it matters: FDA's rare disease development and review overhaul could change regulatory expectations for sponsors of orphan drugs.

Oct 14Wed
  1. fda.gov91

    FDA Approves First Treatment for Certain People With BCG-Unresponsive Bladder Cancer

    The FDA expanded approval of Anktiva (nogapendekin alfa inbakicept-pmln), given with BCG, to adults with BCG-unresponsive, high-grade papillary-only non-muscle invasive bladder cancer, the first FDA-approved treatment for that disease. The decision relied on evidence from Anktiva's earlier approval for carcinoma in situ, where a trial showed a majority of adults achieved a complete response and many maintained it for at least 12 months. The FDA is finalizing draft guidance to let developers use CIS study evidence for papillary-only NMIBC approvals.

    Why it matters: FDA extends Anktiva to BCG-unresponsive papillary-only NMIBC and sets a precedent for cross-indication evidence use.

  2. fda.gov76

    FDA approves an expanded indication for nogapendekin alfa inbakicept-pmln for BCG-unresponsive non-muscle invasive bladder cancer

    On October 14, 2026, the FDA expanded approval of nogapendekin alfa inbakicept-pmln (Anktiva, Altor BioScience, an ImmunityBio subsidiary) with BCG to cover adults with BCG-unresponsive non-muscle invasive bladder cancer with high-grade papillary-only tumors, beyond the prior indication limited to carcinoma in situ. The agency extrapolated efficacy from Cohort A of QUILT-3.032, a single-arm trial of 77 patients, which showed a complete response rate of 62%. The recommended dose is 400 mcg intravesically with BCG weekly for 6 weeks induction, followed by maintenance for up to 37 months.

  3. fda.gov47

    Help More Providers Prescribe with Confidence

    FDA's Center for Drug Evaluation and Research runs Prescribe with Confidence, an educational campaign to help health care providers recognize and treat opioid use disorder and prescribe medications for opioid use disorder when appropriate. The campaign aligns with the Great American Recovery Initiative and lists SAMHSA, NIDA, CDC, HRSA, NRHA, PCSS, the Reagan-Udall Foundation and the American Academy of Family Physicians among its partners. FDA offers free downloadable materials, provider video testimonials and sample social media posts under #PrescribeWithConfidence for organizations to share.

  4. fda.gov43

    BsUFA II: Fiscal Years 2018 - 2022

    FDA is implementing BsUFA II, the Biosimilar User Fee Act programme covering fiscal years 2018 through 2022, under the Biosimilar User Fee Amendments of 2017, Title IV of the Food and Drug Administration Reauthorization Act. The prior BsUFA authority, authorized in 2012 by FDASIA, expired in September 2017, and the FD&C Act required FDA to hold public meetings and negotiate with industry on the reauthorization, including an October 20, 2016 public meeting and steering and finance committee discussions during 2016. The page lists the BsUFA II commitment letter, performance goals, hiring data and implementation plans for enhanced review transparency and communication.

  5. fda.gov45

    Jiangmen Shuizirun Sanitary Articles Co., Ltd. - 722974 - 09/23/2026

    FDA issued a warning letter, reference 320-26-130, to Jiangmen Shuizirun Sanitary Articles Co., Ltd. of Guangdong, China, after a November 3 to 7, 2025 inspection of its drug manufacturing facility documented CGMP violations for finished pharmaceuticals. The firm, whose OTC products are labeled sterile but not sterilized and lack sterility testing at release, also failed to conduct identity testing on incoming components and to validate supplier certificates of analysis. The letter, sent September 23, 2026, asks for an action plan covering customer notifications, recalls or market withdrawals for sterile-labeled batches in U.S. distribution.

  6. fda.gov55

    Hanlim Pharm Co., Ltd. - 734782 - 10/02/2026

    FDA issued a warning letter, reference 320-27-03, to Hanlim Pharm Chairman Jungjin Kim on October 2, 2026, citing significant CGMP violations at the company's sterile drug manufacturing facility in Yonginsi, Gyeonggi-do, inspected from April 16 to April 24, 2026. The letter details poor aseptic practices, inadequate smoke studies and cleanroom design flaws risking product sterility, and calls the company's May 15, 2026 response inadequate. Hanlim must now submit a systematic plan covering aseptic practices, cleanroom behavior and independent assessments, or face seizure or injunction.

    Why it matters: FDA warning letter over CGMP violations at a sterile drug manufacturing site affects Hanlim Pharm's US supply prospects.

  7. fda.gov51

    Eurofins SF Analytical Laboratories, Inc. - 736056 - 10/06/2026

    FDA issued a warning letter dated October 6, 2026 to Eurofins SF Analytical Laboratories, a contract testing laboratory in Horsham, Pennsylvania, after a June 1-3, 2026 inspection documented CGMP violations under 21 CFR parts 210 and 211. FDA found analysts selectively omitted too-numerous-to-count results, recorded counts from cracked and desiccated plates, and lacked secondary verification of zero-CFU readings; the firm admitted inconsistent reporting practices dating back to February 2025. FDA deemed the firm's June 22, 2026 response inadequate and demanded an independent laboratory assessment, a remediation plan, and a CAPA plan, warning that failure to comply may bring seizure or injunction.

  8. fda.gov49

    Silgan Dispensing Systems - 734538 - 10/05/2026

    FDA issued a warning letter dated October 5, 2026, to Earl Lawson, president of Silgan Dispensing Systems, after a March 26 to April 2, 2026 inspection of the Silgan Unicep Packaging facility in Spokane, Washington, which contract manufactures non-sterile over-the-counter drug products. FDA cited CGMP violations including invalidated out-of-specification microbiological results obtained through averaging, an inadequate investigation linked to a customer's Class I recall over potential fungal contamination, and unapproved new drug claims found in product labeling reviewed in July 2026. FDA reviewed the firm's April 22, 2026 response and warned that failure to correct the violations may result in seizure or injunction.

  9. fda.gov49

    Lovelace Biomedical Research Institute - 725136 - 10/06/2026

    FDA issued a Warning Letter to Lovelace Biomedical Research Institute in Albuquerque, citing Good Laboratory Practice violations found during an April 7-18, 2025 inspection under the Bioresearch Monitoring Program. The quality assurance unit failed to review final study reports so that results reflected raw data, omitting abnormal clinical observations in 20 of 34 animals in one protocol and dosing incidents such as pulled catheters and infiltration at the infusion site. FDA found the May 9, 2025 written response and the revised reports dated May 30, 2025 inadequate.

  10. fda.gov50

    SCA Pharmaceuticals, LLC - 724202 - 09/14/2026

    FDA issued a warning letter to SCA Pharmaceuticals, LLC, a 503B outsourcing facility in Little Rock, Arkansas, on September 14, 2026, following an inspection from October 20 to 30, 2025 that found sterile drug products prepared under insanitary conditions. Cited deficiencies include inadequate ISO 5 certification, poor response to microbial contamination, and aseptic technique failures during production of lots such as Fentanyl Citrate 2 mcg/mL Bupivacaine HCl 0.125% and Methadone HCl 10 mg/mL. FDA reviewed the firm's responses of November 21 and December 31, 2025, and deemed the products adulterated under section 501(a)(2)(A) of the FDCA.

Oct 12Mon
  1. fda.gov73

    Hiding in Plain Sight: 7-OH Products

    DEA issued two new Notices of Intent on October 9, 2026, based on updated HHS analysis, proposing threshold-based Schedule I control for 7-hydroxymitragynine (7-OH) and mitragynine pseudoindoxyl (MGPI). HHS recommends Schedule I when either substance, or their combined amount, exceeds 1 milligram per gram in solids or 1 milligram per milliliter in liquids, or when the mitragynine ratio to them falls below 100 to 1. DEA will reissue its Notice of Intent without changing the current scheduling approach for MGM-15 and MGM-16, which were temporarily placed in Schedule I on August 26, 2026; controls stay in effect during the 30-day notice period and until a new temporary scheduling order.

    Why it matters: DEA sets quantitative thresholds that decide which kratom-derived opioid products fall under Schedule I control.

Oct 10Sat
  1. fda.gov87

    FDA Approves Drug to Treat Lesions Caused by Herpes Simplex Virus

    FDA has approved Hovilpri (pritelivir) tablets for immunocompromised adults with mucocutaneous herpes simplex virus lesions who did not respond to acyclovir, valacyclovir or famciclovir. In the Phase 3 PRIOH-1 Part C trial of 101 adults, all lesions healed within 28 days in 63% of pritelivir patients versus 34% on investigator-chosen treatments. The drug received priority review, and headache was the most common adverse reaction.

    Why it matters: First approval of a new mechanism option for immunocompromised HSV patients resistant or intolerant to existing antivirals.

  2. fda.gov40

    Novel Drug Approvals for 2026

    The FDA's novel drug approvals page for 2026 lists 46 approvals to date, from relacorilant for platinum-resistant ovarian cancer on 3/25 through pritelivir for refractory mucocutaneous herpes simplex lesions in immunocompromised adults on 10/9. The list spans oncology, rare disease, metabolic and imaging agents, including orforglipron for obesity, tulisokibart for ulcerative colitis, and two FOP drugs, zilurgisertib and garetosmab. The list is updated as further approvals are granted.

Oct 9Fri
  1. fda.gov49

    Postapproval Manufacturing Changes to Biosimilar and Interchangeable Biosimilar Products: Questions and Answers

    The FDA has issued a final guidance for industry, "Postapproval Manufacturing Changes to Biosimilar and Interchangeable Biosimilar Products: Questions and Answers," from its drug and biologics centers. It answers common questions on postapproval manufacturing changes for biosimilar and interchangeable biosimilar products licensed under the PHS Act. The guidance finalizes a draft of the same title issued on July 23, 2024, under docket FDA-2024-D-2581, and comments may be submitted at any time.

  2. fda.gov93

    FDA approves atezolizumab in combination with chemotherapy for Stage III mismatch repair deficient colon cancer

    The FDA approved atezolizumab (Tecentriq, Genentech) in combination with a fluoropyrimidine and oxaliplatin on October 8, 2026, for adjuvant treatment of Stage III mismatch repair deficient colon cancer in patients two years of age and older, with the subcutaneous Tecentriq Hybreza approved for those 12 years and older weighing 40 kg or greater. In the ATOMIC trial of 711 adults and one pediatric patient, the hazard ratio for disease-free survival was 0.50 versus mFOLFOX6 alone, and median DFS was not reached in either arm. Reviews are ongoing at partner agencies under Project Orbis.

    Why it matters: FDA approval of atezolizumab plus chemotherapy as adjuvant therapy for Stage III dMMR colon cancer, with a disease-free survival hazard ratio of 0.50.

Oct 8Thu
  1. fda.gov41

    Recently Issued Guidance Documents

    The FDA has released a set of guidance documents for industry and agency staff issued from July to September 2026. The list includes final guidances on blood collection and storage systems for blood components using the buffy coat method, formal PDUFA meetings, cancer clinical trial eligibility criteria on laboratory values, washout periods and performance status, and FAQs for cellular and gene therapy products. Draft guidances cover premarket approval electronic submission templates, potency assessment of active immunotherapy products, container closure systems for drugs, biologicals and biosimilars.

  2. fda.gov80

    FDA approves tucatinib with trastuzumab and pertuzumab for the maintenance treatment of HER2-positive breast cancer

    The FDA approved tucatinib (Tukysa, Seagen, a Pfizer subsidiary) with trastuzumab and pertuzumab on October 7, 2026, for maintenance treatment of adults with unresectable locally advanced or metastatic HER2-positive breast cancer after induction therapy. In the 654-patient HER2CLIMB-05 trial, median progression-free survival was 24.9 months with tucatinib 300 mg twice daily versus 16.3 months with placebo (HR 0.64, p<0.0001). The label carries a boxed warning for hepatotoxicity; overall survival data were immature.

    Why it matters: FDA approval extends tucatinib to first-line maintenance, with PFS results from a randomized phase 3 trial.

  3. fda.gov55

    Pharmacokinetics in Patients with Impaired Hepatic Function: Study Design, Data Analysis, and Impact on Dosing

    The FDA's Center for Drug Evaluation and Research issued a draft guidance on studying pharmacokinetics, and where appropriate pharmacodynamics, in patients with impaired hepatic function, including for therapeutic biological products. The non-binding recommendations cover study design, data analysis and impact on dosing for sponsors and applicants. Comments are due by 12/01/2026 under docket FDA-2026-D-8693 before work begins on the final version.

    Why it matters: Draft FDA guidance sets expectations for hepatic impairment PK studies that shape sponsors' clinical development plans.

Oct 7Wed
  1. fda.gov40

    Rare Disease Drug Approvals

    FDA's CDER lists recent rare disease drug approvals on its Accelerating Rare Disease Cures Program page. In 2026 alone these include Camzyos for an inherited heart condition in children, Emcitate for MCT8 deficiency, Isembyld for muscle loss in spinal muscular atrophy, and Zanvastro for Alexander Disease, among others. The list spans 2021 to 2026 and links to the underlying FDA news releases.

Oct 6Tue
  1. fda.gov44

    Online Generic Medicine/www.onlinegenericmedicine.com - 737806 - 09/23/2026

    FDA's Center for Drug Evaluation and Research sent a warning letter dated September 23, 2026 to Online Generic Medicine (www.onlinegenericmedicine.com) for selling unapproved and misbranded injectable semaglutide, including a product marketed as "Semanat Injection (Semaglutide)". The letter cites violations of sections 301(a), 301(d), 301(k), 502(f)(1), 503(b)(1) and 505(a) of the FD&C Act, identified in website reviews on August 26 and September 2, 2026. FDA asks the site to stop offering unapproved and misbranded drugs to U.S. consumers and warns that failure to comply may bring seizure or injunction.

  2. fda.gov46

    TCI Co., Ltd BioCosme PABP BRANCH - 736888 - 09/02/2026

    FDA issued a warning letter to TCI Co., Ltd BioCosme PABP BRANCH, a contract manufacturer of over-the-counter drugs in Pingtung County, Taiwan, citing significant CGMP violations found during an inspection from March 9 to 13, 2026. The firm released OTC drug batches to the U.S. market without assay testing of the active ingredient and failed to perform identity testing on incoming APIs and raw materials or verify supplier certificates of analysis. FDA found the firm's April 2, 2026 response to its Form FDA 483 inadequate and required a comprehensive quality agreement and lists of test methods and specifications; failure to correct the violations may bring regulatory action without further notice.

    Why it matters: FDA warning letter documents CGMP failures at an OTC contract manufacturer supplying the U.S. market.

  3. fda.gov46

    Pine Pharmaceuticals, LLC - 728537 - 08/07/2026

    FDA issued a warning letter dated August 7, 2026 to Pine Pharmaceuticals, LLC, a section 503B outsourcing facility in Tonawanda, New York, after a November 4-14, 2025 inspection found insanitary conditions and CGMP violations that rendered sterile drug products adulterated. Cited failures include inadequate disinfection of materials entering the ISO 5 hood, deficient environmental monitoring of staging trays, and incomplete batch failure investigations. The letter follows the firm's December 8, 2025 response to a Form FDA 483, and FDA expects corrective action.

  4. fda.gov55

    Walmart, Inc. - 736557 - 10/01/2026

    FDA's Center for Drug Evaluation and Research issued a warning letter dated October 1, 2026 to Walmart President and CEO John Furner over three products sold on walmart.com: HClear for him, Herstat GST, and Terragen HG Formula. Purchased by FDA in July 2026 and shipped via Walmart Fulfillment Services, the products are marketed for genital herpes and genital sore symptoms and are unapproved new drugs under section 505(a) of the FD&C Act. FDA notes no OTC drug product is approved for treating any STI and warns that failure to correct the violations may bring seizure or injunction without further notice.

    Why it matters: FDA targets a major retailer for selling unapproved STI products, a direct compliance risk for online drug marketplaces.

  5. fda.gov41

    Aidance Scientific, Inc. - 735346 - 10/01/2026

    FDA's Center for Drug Evaluation and Research issued a warning letter dated October 1, 2026 to Aidance Scientific, Inc. president Perry Antelman, citing the company's "Terragen HG Formula" as an unapproved new drug sold via its website and Amazon storefront for herpes and genital sores. The agency found no approved application for the product and warned that OTC products marketed for STIs pose public health risks, noting homeopathic drugs face the same approval requirements. Failure to correct the violations may prompt seizure or injunction.

  6. fda.gov42

    The Platinum Healthcare LLC - 735147 - 10/01/2026

    FDA's Center for Drug Evaluation and Research issued a warning letter on October 1, 2026 to The Platinum Healthcare LLC and its CEO Jamey Hagan of Pulaski, Tennessee, over products sold on its website. The agency found the homeopathic products "Sycosis" and "Syphillinum," marketed for gonorrhea and syphilis miasms, to be unapproved new drugs violating sections 301(d) and 505(a) of the FD&C Act, noting no OTC product is approved for treating STIs. The company must send a written response to FDA within fifteen business days or face possible seizure and injunction.

  7. fda.gov45

    DesBio/Deseret Biologicals, Inc. - 735464 - 10/01/2026

    FDA's Center for Drug Evaluation and Research sent a warning letter dated October 1, 2026 (reference 735464) to DesBio/Deseret Biologicals CEO Jake Carter, citing the product "CHLA:10M," sold on desbio.com for relief of chlamydia-related symptoms, as an unapproved new drug under sections 301(d) and 505(a) of the FD&C Act. The letter follows a website review in July 2026 and notes that FDA has not approved any OTC drug product for treating or preventing any STI. The company must send a written response to FDAAdvisory@fda.hhs.gov within 15 business days or face possible seizure or injunction.

  8. fda.gov45

    Bioactive Services USA, LLC / Herstat Inc. - 734784 - 10/01/2026

    FDA's Center for Drug Evaluation and Research issued a warning letter on October 1, 2026 to Kevin Aspinall Nessling, CEO of Bioactive Services USA, LLC / Herstat Inc., over the product "Herstat GST", marketed for genital sore treatment on the websites drsosnowski.com and herstat.com. FDA found the product is an unapproved new drug under section 505(a) of the FD&C Act, based on a July 2026 review of the websites and the firm's Facebook and Instagram accounts. FDA notes it has not approved any OTC drug for treating or preventing STIs, and warned that failure to correct the violations may result in seizure or injunction.

  9. fda.gov56

    Amazon.com, Inc. - 736006 - 10/01/2026

    FDA's Center for Drug Evaluation and Research sent a warning letter dated October 1, 2026 (reference 736006) to Amazon CEO Andy Jassy, citing nine products sold on amazon.com and fulfilled via Fulfillment by Amazon, including FemiClear, HClear for him, HerpCare Ointment and Spray, and RoyceDerm Herpes Relief Cream, as unapproved new drugs for genital herpes under section 505(a) of the FD&C Act. FDA, which purchased the products in July 2026, notes no OTC drug is approved for treating any STI and warns that reliance may delay care and risk infertility, sepsis and death. Amazon must correct the violations or face regulatory or legal action including seizure and injunction.

    Why it matters: FDA warning letter puts Amazon's marketplace and Fulfillment by Amazon service directly in the regulatory line for unapproved STI drugs.

  10. fda.gov45

    OrganiCare, LLC / OrganiCare Nature’s Science, LLC - 734925 - 10/01/2026

    FDA's Center for Drug Evaluation and Research sent a warning letter dated October 1, 2026 to Caroline Goodner, CEO of OrganiCare, LLC / OrganiCare Nature's Science, LLC, after a July 2026 review of the femiclear.com website and the company's Facebook and Instagram accounts. The letter states that "HClear for him" and "FemiClear Genital Herpes Symptoms" are unapproved new drugs under section 505(a) of the FD&C Act, marketed without any FDA-approved OTC product for treating STIs. FDA warns that failure to correct the violations may result in seizure and injunction without further notice.

  11. fda.gov40

    Rare Disease News & Events

    The FDA's ARC Program reviewed its 2025 rare disease work, reporting more than 30 public speaking engagements, 57-plus workshops, consults or meetings supporting rare disease drug development, and 45,000 rare disease news subscribers served. CDER approved 46 novel drugs in 2025, with 32 approved first in the U.S. and 23 carrying orphan drug designation. In FY25 the Office of Orphan Products Development granted 450 of 657 original orphan-drug designation requests, and public workshops on rare disease data sharing and neonatal product development are scheduled or archived for 2026.

  12. fda.gov47

    Glenmark Pharmaceuticals Limited - 637314 - 11/22/2022

    The FDA issued a warning letter to Glenmark Pharmaceuticals on November 22, 2022, after inspecting its finished-drug manufacturing facility in Colvale, Goa, from May 12 to May 20, 2022, and finding significant CGMP violations. The letter cites inadequate investigation of out-of-specification results, including 14 rejected batches of desmopressin acetate tablets from 2018 to 2021 and a June 10, 2022 voluntary recall of batch 20220121, plus insufficient process validation for a gel product with five batches rejected for viscosity failures between 2020 and 2021. Glenmark must respond with independent assessments and remediation plans for its investigation and CAPA systems and its process validation program.

  13. fda.gov64

    M15 Resource Center

    The FDA has posted a resource center for ICH M15, a guidance on general principles for model-informed drug development (MIDD). The guidance describes MIDD principles, including planning, model evaluation and evidence documentation, sets a harmonized framework for assessing MIDD-derived evidence, and gives recommendations on MIDD-related regulatory interactions, reporting and submission. FDA recommends sponsors use it when preparing meeting requests, background packages and regulatory submissions.

    Why it matters: FDA now expects ICH M15 principles to shape MIDD evidence in submissions and meetings.

  14. fda.gov49

    CDER Quantitative Medicine Center of Excellence (QM CoE)

    FDA's Center for Drug Evaluation and Research has established a Quantitative Medicine Center of Excellence to coordinate and standardize the use of quantitative medicine in drug development and regulatory decision-making across CDER. The center will work across three areas: Applied Regulatory Science, Enterprise Planning and Coordination, and Education and Ecosystem Development, covering knowledge management, policy development, strategic planning and stakeholder engagement. Its 2025 Progress and Priorities Report sets out recent accomplishments.

  15. fda.gov54

    Expedited Investigational New Drug Pilot Program - Application Instructions

    The FDA has issued application instructions for its Expedited IND Pilot Program. Sponsors and prospective Qualified Research Institutions each complete a form, then the sponsor submits both through the FDA ESG Gateway as one package. The application window stays open for 45 days with possible extension, and FDA scientific experts will review submissions and select 8 to 10 Sponsor-QRI pairs. Participating parties must form their business relationship outside FDA, which will only confirm that an official agreement exists.

    Why it matters: FDA sets out how sponsors and QRIs apply for the Expedited IND Pilot Program and how many pairs will be selected.

Oct 5Mon
  1. fda.gov46

    FDA Seeks Public Input to Support Ibogaine Research

    The FDA issued a request for information on approaches it is considering for designing early-phase clinical trials of ibogaine drug products, covering dose selection and escalation, care setting, safety monitoring, eligibility, stopping rules and safety oversight. Proposed trial elements include small, sequential dose-ascending groups with a starting dose not exceeding 10 mg/kg, and monitoring for cardiac and neurologic adverse events. Comments can be submitted for 45 days via Docket No. FDA-2026-N-10429, closing November 20, 2026, and may inform FDA approaches to ibogaine drug development.

CBACBA Frontier Insights (CFI)Chinese Biopharmaceutical Association (CBA)www.cba-usa.org