FDA Policy/General
The Maryland federal court has granted an FDA request to extend to 9/9 the 5/12 deadline for manufacturers of e-cigarettes, cigars, and other deemed new tobacco products that were on the market as of 8/8/16 to submit applications for premarket review. An agency statement said
FDA Policy/General
Federal Register notice: FDA has extended the comment period on a 1/30-published draft guidance entitled “Interpreting Sameness of Gene Therapy Products Under the Orphan Drug Regulations.” Electronic or written comments can now be submitted by 7/28. To view the notice, click here.
FDA Policy/General
Federal Register notice: FDA has made available a final guidance entitled “Nonbinding Feedback After Certain FDA Inspections of Device Establishments.” The document identifies a standardized method for communicating and submitting requests for nonbinding feedback and describes how FDA evaluates and responds to such requests. To view the notice, click here.
FDA Policy/General
The FDA Office of Minority Health and Health Equity (OMHHE) is marking its 10th anniversary during National Minority Health Month observances in April. In an FDA Voices online post, agency associate commissioner for minority health Richardae Araojo says that in the last 10 years FDA has increasingly focused on and
FDA Policy/General
Former FDA commissioner Donald Kennedy, who served under President Jimmy Carter from 1977 to 1979, died 4/21 due to Covid-19. At the time of his death, Kennedy, 88, resided at Gordon Manor residential care home in Redwood City, CA. During his 26 months at the agency, he dealt
FDA Policy/General
FDA commissioner Stephen Hahn 4/22 provided a teleconference briefing to House Energy and Commerce Committee members on the agency’s response to the coronavirus pandemic. “Today’s conversation helps us continue our oversight responsibilities and will inform our ongoing work to address this terrible pandemic,” committee leaders said in
FDA Policy/General
Federal Register notice: FDA has made available a draft guidance entitled “Technical Considerations for Demonstrating Reliability of Emergency-Use Injectors Submitted under a BLA, NDA or ANDA.” The document focuses on emergency-use injectors marketed with the drug/biological product as a prefilled single entity combination product or as a
FDA Policy/General
FDA has posted its latest batch of Warning Letters that includes one medical product company. It can be accessed by clicking on the link following the summary below: Tenderneeds Fertility, Greenville, IN (4/13) FDA inspected the firm 12/2019 and cited multiple violations in the firm’s work as
FDA Policy/General
[Report by Jim Dickinson] Likening the threat of the Covid-19 pandemic to the peril we defeated in World War II, former FDA commissioner David A. Kessler 4/20 called for a “new social contract” that reduces our usual interpersonal contacts by two-thirds until the virus spread stops. In
FDA Policy/General
Federal Register notice: FDA has postponed until further notice a 5/5-scheduled public meeting entitled “Medical Device User Fee Amendments for Fiscal Years 2023 Through 2027; Public Meeting; Request for Comments.” The public meeting will be rescheduled for a future date and information about the rescheduled meeting will be
FDA Policy/General
Perrigo Company has completed the previously announced acquisition of a portfolio of generic dosage forms and strengths of Retin-A (tretinoin) from Matawan Pharmaceuticals. Perrigo was the authorized generic distributor of these products from 2005-2013. Janssen Pharmaceuticals has suspended dosing in two Phase 2 clinical trials of their FAAH
FDA Policy/General
The Center for Veterinary Medicine (CVM) has sent Warning Letters to two companies it says are distributing unapproved chloroquine phosphate products. The letters went to Fishman Chemical of North Carolina, Vero Beach, FL, and Dr. G’s Marine Aquaculture, Pembroke Pines, FL. In both instances, CVM says its review of
FDA Policy/General
Federal Register notice: FDA has submitted to OMB an information collection revision entitled “Premarket Notification Procedures — 21 CFR Part 807, Subpart E” (OMB Control Number 0910–0120). The revision addresses electronic submission templates that will serve as guided submission preparation tools for industry to improve submission consistency and enhance efficiency
FDA Policy/General
Federal Register notice: FDA has submitted to OMB an information collection extension for “Submission of Information on Pediatric Uses of Medical Devices; Requirement for Submission of Information on Pediatric Subpopulations That Suffer From a Disease or Condition That a Device Is Intended To Treat, Diagnose, or Cure Under Section 515A
FDA Policy/General
Federal Register notice: FDA has submitted to OMB a proposed information collection entitled “FDA Advisory Committee Membership Nominations” (OMB Control Number 0910-0833). To identify and select qualified individuals to serve on its advisory committees, FDA has established an online portal — the FDA Advisory Committee Membership Application — to accept nominations
FDA Policy/General
Federal Register notice: FDA has withdrawn a 3/6 Federal Register notice on a proposed information collection entitled “Food and Drug Administration Safety Communication Readership Survey.” The agency is withdrawing the collection request because it determined that it is more appropriate to include the estimated burden in the agency’s
FDA Policy/General
FDA has posted its latest batch of Warning Letters. They can be accessed by clicking on the link following each letter. American Fertility Medical Center, Irvine, CA (4/2): FDA inspected the firm 1/14-22 and documented significant deviations from the regulations for human cells, tissues, and cellular and
FDA Policy/General
Federal Register notice: FDA has extended the comment period until 6/19 for a request for information entitled “Request for Information on Vaping Products Associated with Lung Injuries” that appeared in the 2/18 Federal Register. To view the notice, click here.
FDA Policy/General
Federal Register notice: FDA has made available a final guidance entitled “Stability Testing of New Veterinary Drug Substances and Medicinal Products in Climatic Zones III and IV.” The International Cooperation on Harmonization of Technical Requirements for Registration of Veterinary Medicinal Products document is intended as an annex to an associated
FDA Policy/General
FDA says it is permitting the use of home-use blood glucose meters by patients with diabetes who are hospitalized due to COVID-19 to check their own blood glucose levels and provide the readings to the health care personnel caring for them. Such use can be an option to
FDA Policy/General
Federal Register notice: FDA has made available two final guidances entitled “Guidance on Chloroquine Phosphate” and “Guidance on Hydroxychloroquine Sulfate.” The documents provide product-specific recommendations on, among other things, the design of bioequivalence studies to support ANDAs. To view the notice, click here.
FDA Policy/General
Notice Corrected on ANDA Approval Withdrawals Federal Register notice: FDA corrects a 1/8 Federal Register notice that announced the withdrawal 23 ANDAs. 04/07/2020 User Fee Report on Drug/Biosimilar Review Resources Federal Register notice: FDA posts a user fee-related report providing options and recommendations for a