FDA Policy/General
Info Collection Extension Sought for Drug GMP Regs Federal Register notice: FDA submits for OMB approval an information collection extension for “Current Good Manufacturing Practice Regulations for Finished Pharmaceuticals (21 CFR parts 210 and 211).” 04/06/2018 FDA Science Board to Meet 4/23 Federal Register notice: FDA announces
FDA Policy/General
Federal Register notice: FDA has announced a 4/23 Science Board Advisory Committee to hear a report from CBER and the committee’s Research Program Review Subcommittee. Panel members will also receive a presentation about FDA’s Patient Affairs Initiative. Additionally, they will discuss how the agency can leverage its
FDA Policy/General
Federal Register notice: FDA has submitted for OMB approval an information collection extension for “Current Good Manufacturing Practice Regulations for Finished Pharmaceuticals (21 CFR parts 210 and 211) OMB Control Number 0910-0139.” To view the notice, click here.
FDA Policy/General
Federal Register notice: FDA is seeking comments on the drug industry’s use of exposure-response analyses, particularly as it relates to recommendations in a 2003 guidance entitled Exposure-Response Relationships — Study Design, Data Analysis, and Regulatory Applications. The agency is interested in identifying areas of scientific policy that may
FDA Policy/General
Federal Register notice: FDA has made available a guidance entitled “Liposome Drug Products: Chemistry, Manufacturing, and Controls; Human Pharmacokinetics and Bioavailability; and Labeling Documentation.” The document provides recommendations to applicants on related sections in NDAs and ANDAs. To view the notice, click here.
FDA Policy/General
FDA says growth in its user fee programs in terms of scope of activities and the volume and complexity of submissions has increased operational demands on the agency. “To help ensure that the agency is making optimal use of its financial resources to maximize its ability to efficiently and effectively
FDA Policy/General
Federal Register Final Rule: FDA has amended the animal drug regulations to reflect application-related actions for NADAs and ANADAs during October, November, and December 2017. The agency is making available summaries of their basis for approval. The regulations are also being amended to reflect sponsorship changes to applications and
FDA Policy/General
Federal Register Final Rule; technical amendment: FDA has amended certain medical device regulations to correct editorial issues, such as typographical errors, and to ensure accuracy and clarity in the regulations. The changes also update addresses, office titles, and wording to ensure accuracy. To view the notice, click here.
FDA Policy/General
Federal Register notice: FDA has withdrawn approval of five NDAs because the drug products are no longer marketed and the sponsors requested the action. To view the notice, click here.
FDA Policy/General
Industria Farmacéutica Andrómaco (Toluca, Mexico) has recalled topical drug product Pasta De Lassar Andromaco zinc oxide diaper rash treatment after an FDA laboratory analysis confirmed its contamination with high levels of yeast, mold, and bacteria. “This is especially concerning because Pasta De Lassar Adromoca is labeled for use to relieve
FDA Policy/General
Federal Register notice: FDA has issued an order withdrawing approval of ANDAs for certain prescription laxatives with the active ingredient polyethylene glycol 3350 (PEG 3350) because the drug products are misbranded. The order is in response to a change in Braintree Labs’ MiraLAX’s status from prescription to nonprescription status.
FDA Policy/General
Federal Register notice: FDA has made available a draft five-year plan describing its approach to further implement a structured benefit-risk assessment that includes the patient’s voice in drug development and decision-making. The new draft plan is an update to a similar plan published in 2013. To
FDA Policy/General
Federal Register Final Rule; technical amendment: FDA is amending its good guidance practices regulation to inform the public on how to electronically submit a draft of a proposed guidance to the agency. The amendment provides an option for submitting such drafts electronically through regulations.gov at Docket No. FDA-2013-
FDA Policy/General
Federal Register notice: FDA has announced a 5/11 public workshop on medical gas regulation entitled “Medical Gas Regulation: Workshop 3.” The topic to be discussed is potential areas for drug regulation that should be revised for medical gases. To view the notice, click here.
FDA Policy/General
Joint Panel to Discuss Celebrex Safety Data Federal Register notice: FDA announces a 4/24-25 joint Arthritis Advisory Committee and Drug Safety and Risk Management Advisory Committee meeting to discuss Celebrex safety v. ibuprofen or naproxen. 03/30/2018 Workshop on Generic Regulatory Science Initiatives Federal Register notice: FDA
FDA Policy/General
Federal Register notice: FDA has announced a 5/24 public workshop on “FY 2018 Generic Drug Regulatory Science Initiatives” to provide an overview of regulatory science initiatives for generic drugs and an opportunity for public input. The workshop is mandated by the recent user fee agreement to develop an annual
FDA Policy/General
Federal Register notice: FDA has announced a 4/24-25 joint Arthritis Advisory Committee and Drug Safety and Risk Management Advisory Committee meeting. Panel members are scheduled to discuss a Pfizer supplemental NDA for Celebrex (celecoxib) capsules and the results from the PRECISION (Prospective Randomized Evaluation of Celecoxib Integrated Safety
FDA Policy/General
Federal Register notice: FDA has announced a 5/22 joint Anesthetic and Analgesic Drug Products Advisory Committee and Drug Safety and Risk Management Advisory Committee advisory committee meeting. Panel members are scheduled to discuss an Insys Development NDA for buprenorphine sublingual spray, indicated for treating moderate-to-severe acute pain
FDA Policy/General
Federal Register notice: FDA has made available a revised draft guidance on generic doxycycline hyclate oral delayed-release tablets, entitled “Product-Specific Guidance for Doxycycline Hyclate.” The document provides product-specific recommendations on bioequivalence study designs to support ANDAs for such rug products. To view the notice, click here.
FDA Policy/General
Federal Register notice: FDA has submitted for OMB approval a new information collection entitled “Guidance for Industry on Compounded Drug Products That Are Essentially Copies of a Commercially Available Drug Product Under Section 503B of the Federal Food, Drug, and Cosmetic Act.” Section 503B describes conditions that must be met
FDA Policy/General
Federal Register notice: FDA has renewed for an additional two years the charter for its Gastrointestinal Drugs Advisory Committee. Authority for the advisory committee will expire 3/3/2000. To view the notice, click here.
FDA Policy/General
Federal Register notice: FDA has announced a 5/3 joint Gastrointestinal Drugs Advisory Committee and Pediatric Advisory Committee meeting. Panel members are scheduled to review an InfaCare Pharmaceutical NDA for stannsoporfin intramuscular injection, indicated for treating neonates greater than or equal to 35 weeks of gestational age with indicators of