FDA Policy/General
Federal Register notice: FDA is seeking comments on a proposed information collection entitled “Risk/Safety Considerations and Motivations for Purchase and Use of Kratom and Psychedelics Alone and in Combination With Other Substances.” The collection is intended to support scientific research to address emerging data on kratom and psychedelics suggesting
FDA Policy/General
Federal Register notice: FDA is announcing the renewal of its Psychopharmacologic Drugs Advisory Committee for an additional two years beyond the charter expiration date. The new charter will be in effect until 6/4/2026. To view the notice, click here.
FDA Policy/General
Federal Register notice: FDA is announcing biosimilar user fee rates for fiscal year 2025. They are: * Applications requiring clinical data — $1,471,118 * Applications not requiring clinical data — $735,559 * Biological product development program fee — $256,168 To view the notice, click here.
FDA Policy/General
Federal Register notice: FDA is announcing the over-the-counter monograph order request (OMOR) fee rates for fiscal year 2025. They are: * OMOR: Tier 1 — $559,777 * OMOR Tier 2 — $111,955
FDA Policy/General
Federal Register notice: FDA is seeking comments on an information collection extension entitled “Generic Clearance for Quantitative Testing for the Development of FDA Communications.” The collection supports FDA’s use of quantitative social/behavioral science data collection techniques (i.e., surveys and experimental studies) to test consumers’ reactions to FDA
FDA Policy/General
Federal Register notice: FDA is announcing the medical device user fee rates for fiscal year 2025. They are: * Premarket application — $540,783 * Panel-track supplement — $432,626 * De novo classification request — $162,235 * 180-day supplement — $81,117 * Real-time supplement — $37,855 * 510(k) submission — $24,335 * Annual fee
FDA Policy/General
Federal Register notice: FDA is announcing fiscal year 2025 rates for generic drug user fees. They are: * ANDA — $321,920 * Drug master file — $95,084 * Active pharmaceutical ingredient (API) domestic facility — $41,580 * API foreign facility — $56,580 * Finished dosage form (FDF) domestic — $231,952 * FDF foreign — $246,952 * Contract
FDA Policy/General
Federal Register notice: FDA is announcing the renewal of its Pharmacy Compounding Advisory Committee for an additional two years. The new charter will be in effect until 4/25/2026. To view the notice, click here.
FDA Policy/General
Federal Register notice: FDA is withdrawing approval of 23 ANDAs from multiple applicants after they notified the agency that the products are no longer being marketed and requested their withdrawal. To view the notice, click here.
FDA Policy/General
Federal Register notice: FDA is announcing the renewal for two years of its Pulmonary-Allergy Drugs Advisory Committee. The new charter will be in effect until 5/30/2026. To view the notice, click here.
FDA Policy/General
Federal Register notice: FDA announces a 9/18 Pediatric Advisory Committee meeting that will discuss post-marketing pediatric-focused safety reviews on 41 products.
FDA Policy/General
FDA has published a Veterinary International Conference on Harmonization guidance, Impurities: Residual Solvents in New Veterinary Medicinal Products, Active Substances and Excipients (Revision 2), that recommends acceptable amounts of residual solvents in pharmaceuticals for the safety of the target animal and for the safety of residues in products derived from
FDA Policy/General
Federal Register notice: FDA is making available a final guidance entitled ‘‘Real-World Data: Assessing Electronic Health Records and Medical Claims Data To Support Regulatory Decision-Making for Drug and Biological Products.” The document is intended to provide sponsors and other interested parties with considerations when proposing to use electronic
FDA Policy/General
House Republican leaders have scrapped a floor vote this week on FDA’s fiscal year 2025 budget. Capitol Hill reports indicate that Republican lawmakers are not in agreement on whether the funding measure should contain language that would have limited access to the abortion pill mifepristone. With no sure path
FDA Policy/General
Federal Register notice: FDA is announcing that it revoked a Mesa Biotech emergency use authorization for the Accula SARS-CoV-2 Test. The company says it is no longer marketing the test and asked that its authorization be revoked. To view the notice, click here.
FDA Policy/General
Federal Register notice: FDA is extending the comment period on its 6/26-released “Information Technology (IT) Strategy” and “Customer Experience Strategy.” Comments can now be submitted until 8/30. To view the notice, click here.
FDA Policy/General
Federal Register notice: FDA is announcing that OMB has approved an information collection entitled “Survey on Quantitative Claims in Direct-to-Consumer Prescription Drug Advertising.” This type of (XXX SUBSTITUTE XXX)advertising may make quantitative claims about a drug’s efficacy or risks, and the agency has research and guidance
FDA Policy/General
Federal Register notice: FDA is correcting a 7/2 notice that announced the determination of the regulatory review period for Sanofi’s Xenpozyme (olipudase alfa-rpcp) for patent extension purposes. The document was published with an incorrect patent number, and this notice corrects that. To view the notice, click here.
FDA Policy/General
New studies by FDA drug promotion staff found that consumers conflated a drug’s benefits and risks when they were exposed to both a disease awareness communication and drug advertisement. “Participants more often incorrectly attributed benefits of using the drug to treat or manage the disease (asthma) when the disease
FDA Policy/General
Federal Register notice: FDA is seeking comments on an information collection entitled “Diversity Action Plans (DAPs) for Clinical Studies.” The collection supports Sections 3601 and 3602 of the Food and Drug Omnibus Reform Act of 2022 that stipulates that a DAP must include the sponsor’s goals for enrollment in
FDA Policy/General
Federal Register notice: FDA is making available a draft guidance entitled “Pediatric Inflammatory Bowel Disease: Developing Drugs for Treatment.” The document provides FDA’s recommendations about the necessary attributes of clinical studies for drugs being developed for treating pediatric ulcerative colitis or pediatric Crohn’s disease, including study population, study
FDA Policy/General
Federal Register notice: FDA is making available a final guidance entitled “Blood Pressure and Pulse Donor Eligibility Requirements: Compliance Policy.” The document addresses certain regulatory requirements for determining donor eligibility that apply to establishments that collect blood and blood components for transfusion or for further manufacturing use, including source plasma.