FDA Policy/General
The DC federal court has dismissed a complaint filed by an attorney identified as J. Doe seeking to keep the attorney’s identity secret in connection with a form FDA-483 that was scheduled to be published. The court granted an FDA motion to dismiss the complaint under the Federal
FDA Policy/General
It’s official: Johns Hopkins surgeon and public policy researcher Marty Makary (see earlier story) was nominated late 11/22 by president-elect Donald Trump as FDA commissioner. Makary was selected to correct FDA’s course, according to Trump, who says the agency has “lost the trust of Americans, and
FDA Policy/General
Federal Register notice: FDA is making available a final guidance entitled “510(k) Third Party Review Program and Third-Party Emergency Use Authorization (EUA) Review.” The document provides the agency’s current thinking regarding the alternative process for manufacturers to seek 510(k) submission reviews and EUAs. To view the
FDA Policy/General
Federal Register notice: FDA has determined that Renew Pharmaceuticals’ IC-Green (indocyanine green) was not withdrawn from sale for reasons of safety or effectiveness. The determination will allow the agency to approve ANDAs that reference the product if all other legal and regulatory requirements are met. IC-Green is indicated
FDA Policy/General
Johns Hopkins surgeon and public policy researcher Marty Makary is reportedly on the shortlist to be nominated by president-elect Donald Trump as FDA commissioner under his new administration. Trump aids are offering words of caution that the pick is not final, according to a Bloomberg news report. “President-elect
FDA Policy/General
Federal Register notice: FDA has determined that Endo’s Fortesta (testosterone) gel, 10 mg/0.5 g, was not withdrawn due to safety or effectiveness reasons. The determination permits the agency to approve ANDAs that reference the drug product as long as they meet relevant legal and regulatory requirements. Fortesta
FDA Policy/General
After a one-year implementation period, new FDA standards became effective 11/20 requiring drug marketers to ensure their direct-to-consumer advertisement’s “major statement” is presented in a clear, conspicuous, and neutral manner. The five standards, outlined in an 11/20/2023 final rule entitled, “Direct-to-Consumer
FDA Policy/General
Federal Register notice: FDA is revoking the Emergency Use Authorizations issued to Cue Health for the Cue Covid–19 Test, and Cue Covid–19 Home/OTC Test after the company requested the action because the tests are no longer being made and distributed. To view the notice, click here.
FDA Policy/General
Federal Register notice: FDA is making available additional draft and revised draft product-specific guidances for generic drug sponsors. The documents provide product-specific recommendations on, among other things, the design of bioequivalence studies to support ANDA submissions. To view the notice, click here.
FDA Policy/General
Federal Register notice: FDA is making available a draft guidance entitled “Frequently Asked Questions — Developing Potential Cellular and Gene Therapy Products.” The document provides industry with answers to frequently asked questions (FAQs) and commonly faced issues that arise during the development of cellular and gene therapy products. The FAQs represent
FDA Policy/General
Federal Register notice: FDA has determined that GlaxoSmithKline’s Jesduvroq (daprodustat) tablets were not withdrawn due to safety or effectiveness reasons. This action will allow the agency to approve ANDAs that reference the product if all other legal and regulatory requirements are met. Jesduvroq is a hypoxia-inducible factor prolyl
FDA Policy/General
Federal Register notice: FDA is issuing an order permanently debarring Ivette Maria Portela Martinez from providing services to a person that has an approved or pending drug product application. The order is based on her felony conviction arising from drug development work at AMB Research Center (Miami, FL) where she
FDA Policy/General
Federal Register notice: FDA has determined that Merck’s Hydrocortone (hydrocortisone sodium phosphate) injection, equivalent to 50 mg/mL, was not withdrawn due to safety or effectiveness reasons. The determination will allow the agency to approve ANDAs that reference the product if all other legal and regulatory requirements are met.
FDA Policy/General
Federal Register notice: FDA is seeking comments on an information collection revision entitled “Prescription Drug User Fee Program.” The agency is revising the collection to include its current commitment goals from the document “PDUFA Reauthorization Performance Goals and Procedures Fiscal Years 2023 Through 2027. The commitment goals represent agreements reached
FDA Policy/General
President-elect Donald Trump’s pick as HHS secretary Robert F. Kennedy Jr. is promising to “free the agencies,” including FDA, “from the smothering cloud of corporate capture so they can pursue their mission to make Americans once again the healthiest people on Earth. In a 11/15 statement delivered
FDA Policy/General
President-elect Donald Trump has announced that he will nominate controversial FDA critic and vaccine skeptic Robert F. Kennedy Jr. as his secretary for Health and Human Services. “For too long, Americans have been crushed by the industrial food complex and drug companies who have engaged in deception, misinformation, and
FDA Policy/General
Federal Register notice: FDA is making available a draft guidance entitled “Nonclinical Safety Assessment of Oligonucleotide-Based Therapeutics.” The document provides recommendations on approaches for the nonclinical safety evaluation of oligonucleotide-based therapeutics (ONTs) to support clinical development and their marketing. The agency notes that ONTs “present unique challenges and
FDA Policy/General
The CDER Office of Prescription Drug Promotion (OPDP) says a Merz Pharmaceutical promotion for Xeomin (incobotulinumtoxinA) for injection, for intramuscular or intraglandular use, featuring paid celebrity spokesman Nate Berkus, makes false or misleading representations and suggestions about the risks and efficacy of the drug. A 10/31 Notice of Violation
FDA Policy/General
Federal Register notice: FDA is announcing a 12/12 public workshop titled “Optimizing the Use of Real-World Evidence in Regulatory Decision-Making for Drugs and Biological Products — Looking Forward.” It is intended to provide an update on FDA’s current activities related to real-world evidence and to share
FDA Policy/General
FDA commissioner Robert Califf says he is “personally disappointed” in the election results that will see another Trump administration overseeing the agency. Speaking during a virtual keynote address at the Friends of Cancer Research 11/12, Califf said that “it’s pretty clear that the gist of [the Trump] administration,
FDA Policy/General
[Commentary by David McFarland] Who will be the next FDA commissioner and what health role will Robert F. Kennedy Jr. play (see earlier story) in president-elect Donald Trump’s next administration? These are some of the top unanswered questions agency watchers are mulling just two days after his unprecedented
FDA Policy/General
Federal Register notice: FDA is making available a proposed administrative order entitled “Amending Over-the-Counter Monograph M012: Cold, Cough, Allergy, Bronchodilator, and Antiasthmatic Drug Products for Over-the-Counter Human Use.” If finalized, it would remove orally administered phenylephrine hydrochloride and phenylephrine bitartrate in an effervescent dosage as nasal