FDA Policy/General
Federal Register notice: FDA has announced a 5/11-12 Oncologic Drugs Advisory Committee’s Pediatric Oncology Subcommittee meeting. On 5/11, the subcommittee will discuss the development and successful implementation of the Pediatric Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events as a tool for
FDA Policy/General
Federal Register notice: FDA, the National Institute of Allergy and Infectious Diseases, and the Centers for Disease Control and Prevention are announcing a 4/23 public workshop entitled “Development Considerations of Antimicrobial Drugs for the Treatment of Gonorrhea.” The workshop is intended to discuss the nonclinical and clinical pharmacology data
FDA Policy/General
Federal Register notice: FDA has submitted to OMB an information collection extension entitled “Formal Dispute Resolution: Scientific and Technical Issues Related to Pharmaceutical Current Good Manufacturing Practice” (OMB Control Number 0910-0563). FDA regulations establish dispute resolution procedures to ensure appropriate review of scientific controversies between FDA and members of
Drugs
FDA says its inspection of records supplied at the agency’s request by Proquimes SA Productos Quimicos Especializados, a registered manufacturer of active pharmaceutical ingredients (API) located in Cali, Colombia, identified significant deviations from current good manufacturing practice (CGMP) for APIs. A 4/5 Warning Letter says specific deviations were:
FDA Policy/General
Writing in a From a Global Perspective article, two staffers from the FDA Global Engagements Team and one from CVM outline several of the successes that have occurred under the U.S.-Canada Regulatory Cooperation Council (RCC) that was created 10 years ago. The article notes that even before the
Drugs
Public Citizen is petitioning FDA to add all drug products containing lorcaserin HCl and all parenteral drug products containing bacitracin to the list of drugs that may not be compounded after being withdrawn from the market for reasons of safety or effectiveness. The advocacy group’s 4/13 petition also
Drugs
Braintree is petitioning FDA not to approve under sections 505(b) and 505(j) of the Federal Food, Drug, and Cosmetic Act any NDA or ANDA for a tablet-based or tablet-containing colonoscopy preparation unless it contains a specification ensuring that the tablet formulation will not inhibit or interfere
Drugs
The 5th Circuit Court of Appeals says the Federal Trade Commission (FTC) did not commit any legal errors and had sufficient substantial evidence to support its factual finding that Impax Laboratories violated antitrust law by accepting payments from Endo worth more than $100 million to delay the entry of its
Drugs
FDA 4/1 issued a Warning Letter to Maison Terre after conducting testing on its drug product labeled as “Goldenseal Root Powder Organic” and determining the repackaged product was prepared, packed, or held under insanitary conditions. The letter said the agency was aware of a report of one infant death
Drugs
Attorney Andrew Goldfarb (Zuckerman Spaeder) says the Senate approved 3/11 S. 415, a bill that would amend the Federal Food, Drug, and Cosmetic Act to replace the phrase “active ingredient (including any ester or salt of the active ingredient)” with FDA’s regulatory definition of “active moiety.” Goldfarb writes
FDA Policy/General
Federal Register notice: FDA is reopening the comment period on an 11/16/2020 public meeting that requested public input on a potential revised approach for considering the human medical importance of antimicrobial new animal drugs when assessing and managing the antimicrobial resistance risks associated with using such drugs in
FDA Policy/General
Federal Register notice: FDA is requesting that public stakeholders notify it if they want to participate in periodic consultation meetings on reauthorizing the Animal Generic Drug User Fee Act. The Federal Food, Drug, and Cosmetic Act requires that FDA consult with a range of stakeholders in developing recommendations for the
FDA Policy/General
Federal Register notice: FDA is requesting that public stakeholders notify it if they want to participate in periodic consultation meetings on reauthorizing the Animal Drug User Fee Act. The Federal Food, Drug, and Cosmetic Act requires that FDA consult with a range of stakeholders in developing recommendations for the next
Drugs
FDA acting commissioner Janet Woodcock has announced that CDER deputy director for operations Patrizia Cavazzoni has been appointed to her former position as CDER director, a post that Cavazzoni has served in an acting capacity for the past year while Woodcock was on detail at Operation WarpSpeed. Cavazzoni has more
Devices
FDA has classified as Class 1 a Medtronic recall of all unused Valiant Navion thoracic stent grafts due to stent fractures and endoleak concerns. “Following device implantation, patients may experience stent ring enlargement beyond design specification, stent fractures, holes in the graft fabric (Type III endoleaks), life-threatening bleeding, aortic
Devices
Smisson-Cartledge Biomedical has recalled (Class 1) its ThermaCor 1200 Rapid Thermal Infusion System Disposable Sets because a cassette that warms fluids directly with an aluminum plate may leak aluminum into the fluids and expose patients to high levels of the metal. The recall is specific to the disposable cassette
Devices
FDA has granted Cosmo Artificial Intelligence a de novo marketing authorization for the GI Genius, the first device that uses artificial intelligence based on machine learning to assist clinicians in detecting lesions (such as polyps or suspected tumors) in the colon in real time during a colonoscopy. The authorization was
FDA Policy/General
Federal Register notice: FDA is withdrawing approval of five ANDAs from multiple holders because they have repeatedly failed to file required annual reports and satisfy a requirement to have an approved risk evaluation and mitigation strategy. To view the notice, click here.
FDA Policy/General
Federal Register notice: FDA has announced a 5/20 public meeting entitled “Animal Drug User Fee Act.” The meeting is intended to invite public comment on the user fee program and suggestions about certain features the agency should consider for the next program reauthorization. To view the notice, click here.
FDA Policy/General
Federal Register notice: FDA is announcing a 5/20 public meeting entitled “Animal Generic Drug User Fee Act.” The meeting will invite public comment on the user fee program and suggestions about features the agency should consider for the next program reauthorization. To view the notice, click here.
Biologics
FDA has told Provention Bio that it has identified deficiencies with its BLA for diabetes therapy teplizumab that preclude labeling and post-marketing requirements/commitments discussions at this time. The agency’s notification stated the deficiencies do not reflect a final decision on the information under review, the company says.
Drugs
FDA has told Iterum Therapeutics that it needs more time to review company-submitted “materials” related to the ongoing NDA review for (XXX DELETE sulopenem etzadroxil/probenecid for treating uncomplicated urinary tract infections in patients with a quinolone non-susceptible pathogen. A previously scheduled 6/2 Antimicrobial Drugs Advisory Committee