FDA Policy/General
Federal Register notice: FDA is issuing an order permanently debarring Maria Anzures-Camarena from providing services in any capacity to any person/entity that has an approved or pending drug product application. FDA bases the order on Anzures-Camarena’s recent guilty plea regarding her involvement in a conspiracy with
FDA Policy/General
Federal Register notice: FDA is seeking comments on an OMB information collection extension entitled “De Novo Classification Process (Evaluation of Automatic Class 3 Designation) — 21 CFR Part 860, Subpart D.” The collection supports agency regulations that establish a “De Novo” classification process and govern format and content elements for De
FDA Policy/General
Federal Register notice: FDA is announcing the issuance of an emergency use authorization for Invivyd’s Pemgarda (pemivibart) for use as Covid-19 pre-exposure prophylaxis in certain adults and adolescents. Pemgarda is a recombinant monoclonal lgGh antibody that targets the Covid spike protein receptor binding domain, thereby inhibiting virus
FDA Policy/General
Federal Register notice: CDER is proposing to withdraw approval of four NDAs and is announcing an opportunity for the application holders to request a hearing on the proposal. The basis for the action is that the NDA holders have repeatedly failed to file required annual reports. The affected products are:
FDA Policy/General
Federal Register notice: FDA is issuing a priority review voucher to Pfizer after determining that its Paxlovid (nirmatrelvir co-packaged with ritonavir) tablets meet the criteria for a material threat medical countermeasure product application. The drug was approved 5/2023 for treating mild-to-moderate Covid-19. To view the
FDA Policy/General
Federal Register notice: FDA is issuing an order permanently debarring Jessica Palacio from providing services in any capacity to a person that has an approved or pending drug product application. The order is based on Palacio’s felony conviction for false statements she gave to FDA as the study coordinator
FDA Policy/General
Federal Register notice: FDA is making available a draft revised guidance entitled “Studies to Evaluate the Safety of Residues of Veterinary Drugs in Human Food: Reproduction Testing (Revision 1).” The document is intended to help ensure international harmonization of reproduction testing that is appropriate for the evaluation of effects on
FDA Policy/General
Federal Register notice: FDA is extending the comment period on its proposed rule entitled “Labeling Requirements for Approved or Conditionally Approved New Animal Drugs.” The agency now will accept comments until 8/9. To view the notice, click here.
FDA Policy/General
Federal Register notice: FDA is requesting that any industry organizations interested in participating in the selection of nonvoting industry representatives to serve on certain panels of CDRH’s Medical Devices Advisory Committee notify it in writing. The agency is also requesting nominations for nonvoting industry representatives to serve on certain
FDA Policy/General
Federal Register notice: FDA is announcing a 7/11 public workshop entitled “Evaluating Immunosuppressive Effects of In Utero Exposure to Drug and Biologic Products.” The workshop is intended to discuss transplacental transfer of drug and biological products with immunosuppressive properties and the potential clinical impact on the developing fetus and
FDA Policy/General
Federal Register notice: FDA is reinstating an information collection entitled “Yale-Mayo Clinic Centers of Excellence in Regulatory Science and Innovation (CERSI) B12 Pediatric Device Survey.” The survey collection supports FDA’s interests and efforts to increase the number of devices approved for use in pediatric patients. The agency is
FDA Policy/General
Federal Register notice: FDA is announcing that its previously postponed 5/16 meeting of the Vaccines and Related Biological Products Advisory Committee has been rescheduled to 6/5. Panel members are scheduled to discuss and make recommendations on the selection of the 2024 to 2025 formula for Covid-19 vaccines.
FDA Policy/General
Federal Register notice: FDA is issuing a final order reclassifying the ultrasound cyclodestructive device, a postamendments Class 3 device (product code LZR), into Class 2 (special controls), subject to premarket notification. The agency is also establishing special controls that are necessary to provide a reasonable assurance of safety and effectiveness
FDA Policy/General
Federal Register notice: FDA is announcing the withdrawal of the Center for Veterinary Medicine’s (CVM’s) Program Policy and Procedures Manual Guide 1240.3605 Regulating Animal Foods with Drug Claims. The 1998 document offered guidance to CVM staff for regulating animal food that may have intended uses that result
FDA Policy/General
Federal Register notice: FDA is announcing the revocation of the emergency use authorizations (EUAs) issued to Bio-Rad Laboratories for the Bio-Rad SARS–CoV–2 ddPCR Kit, and Siemens’ Fast Track Diagnostics Luxembourg for the FTD SARS–CoV–2. Both companies have told the agency that their Covid-19
FDA Policy/General
Federal Register notice: FDA is making available additional draft and revised draft product-specific guidances that provide recommendations on, among other things, the design of bioequivalence studies to support ANDAs. To view the notice, click here.
FDA Policy/General
Federal Register notice: FDA is announcing the issuance of emergency use authorizations (EUAs) for certain medical devices related to Covid-19. The authorizations contain, among other things, conditions on the emergency use of the authorized products. They also contain an explanation of the reasons for issuance, and each can be
FDA Policy/General
The Alliance for a Stronger FDA is urging Congress to provide FDA with $3.9 billion in budget authority (excludes user fee funding) for salaries and expenses for fiscal year (FY) 2025, which is more than $200 million (5%) above President Biden’s recent budget request (see earlier story) and
FDA Policy/General
Federal Register notice: FDA is announcing the issuance of a priority review voucher to X4 Pharmaceuticals in response to gaining approval of a rare pediatric disease product application — Xolremdi (mavorixafor), indicated for treating patients 12 years of age and older with WHIM syndrome (warts, hypogammaglobulinemia, infections and myelokathexis). To view
FDA Policy/General
Federal Register notice: FDA is issuing an order permanently debarring Gina Acosta from providing services in any capacity to a person that has an approved or pending drug product application. FDA is basing the order in Acosta’s felony conviction on her conspiracy with drug traffickers to distribute misbranded and
FDA Policy/General
Federal Register notice: FDA is publishing a technical amendment to its animal drug regulations for labeling new animal drugs included on the agency’s Index of Legally Marketed Unapproved New Animal Drugs for Minor Species to reflect the 2018 statutory changes to the Federal Food, Drug, and Cosmetic Act. The
FDA Policy/General
Marking the 30th anniversary of the establishment of the FDA Office of Women’s Health (OWH), FDA commissioner Robert Califf and associate commissioner for women’s health Kaveeta Vasisht write in an online post that OWH has been “at the forefront of ensuring that the unique health needs of women