FDA Policy/General
Federal Register notice: FDA has determined that Pfizer’s Vistaril (hydroxyzine pamoate) oral suspension, 25 mg/5 mL, was not withdrawn from sale for reasons of safety or effectiveness. The determination will allow FDA to approve ANDAs that reference the product if all other legal and regulatory requirements are met.
FDA Policy/General
Federal Register notice: FDA is announcing that it has issued a priority review voucher to Italfarmaco SpA for being the sponsor of a rare pediatric disease product application. FDA has determined that the company’s 3/21-approved Duvyzat (givinostat), indicated for treating Duchenne muscular dystrophy in patients six years
FDA Policy/General
Federal Register notice: FDA is making available its annual compilation of update notices to the agency’s Susceptibility Test Interpretive Criteria Web page. The Web site and subsequent annual posting are mandated by the 21st Century Cures Act, which clarified FDA’s authority to identify and efficiently update susceptibility test
FDA Policy/General
Researchers in the CDER Office of Prescription Drug Promotion say they found that prominently disclosing information related to the methodological rigor of a study may help healthcare professionals form an accurate perception of the strength of the study and support for any claims that may be in promotional communications. The
FDA Policy/General
Federal Register notice: FDA is requesting nominations for voting members, excluding consumer and industry representatives, to serve on CDRH’s Patient Engagement Advisory Committee. The agency says nominations received on or before 6/4 will be given first consideration for committee membership To view the notice, click here.
FDA Policy/General
Federal Register notice: FDA is announcing a 6/6 public meeting entitled “Financial Transparency and Efficiency of the Prescription Drug User Fee Act, Biosimilar User Fee Act, and Generic Drug User Fee Amendments.” The meeting will include presentations from the agency on the five-year plan for user fee programs,
FDA Policy/General
Federal Register notice: FDA determines that 24 listed drug products were not withdrawn from sale for reasons of safety or effectiveness. The determination allows the agency to continue to approve ANDAs that reference a listed products as long as they meet relevant legal and regulatory requirements. To view the notice,
FDA Policy/General
Federal Register notice: FDA is issuing an order to debar for five years Robert Lance Shuffert from importing or offering for import any drug into the U.S. The order is based on a finding that Shuffert was convicted of one felony count of intent to defraud and mislead, causing
FDA Policy/General
Federal Register notice: FDA is seeking industry organizations interested in selecting a nonvoting industry representative to serve on CDRH’s Device Good Manufacturing Practice Advisory Committee. The agency is also requesting nominations for a nonvoting industry representative to fill an upcoming vacancy on the committee. A nominee may either be
FDA Policy/General
Federal Register notice: FDA is announcing a 5/22 Pediatric Oncology Subcommittee of the Oncologic Drugs Advisory Committee meeting. Panel members will discuss the implementation of amendments to section 505B of the Federal Food, Drug, and Cosmetic Act that requires pediatric investigations of certain targeted cancer drugs for original applications
FDA Policy/General
FDA commissioner Robert Califf is scheduled to testify before the House Committee on Oversight and Accountability 4/11 at a hearing that’s likely to ratchet up political pressure through intensifying committee investigations into FDA responses to several issues, including drug shortages, facility inspections, hemp regulation, regulation of tobacco and
FDA Policy/General
Federal Register notice: FDA is making available a draft guidance entitled “New Dietary Ingredient Notification Master Files for Dietary Supplements.” The document provides recommendations to the dietary supplement industry on master files for new dietary ingredients. It is intended to help industry comply more easily with the new dietary ingredient
FDA Policy/General
Federal Register notice: FDA is making available a draft guidance entitled “Data Integrity for In Vivo Bioavailability and Bioequivalence Studies.” The document provides recommendations to applicants and testing site management on maintaining data integrity for the clinical and bioanalytical portions of bioavailability and bioequivalence studies submitted in support of drug-
FDA Policy/General
Federal Register notice: FDA is making available a draft guidance entitled “Draft Guidance on Oxymetazoline Hydrochloride.” The document, when finalized, will provide product-specific recommendations on, among other things, the design of bioequivalence studies to support ANDAs for oxymetazoline hydrochloride ophthalmic solution, which is used in patients with blepharospasm to
FDA Policy/General
Federal Register notice: FDA is making available a final guidance entitled “Providing Regulatory Submissions in Electronic Format: IND Safety Reports.” The document describes the electronic format sponsors will be required to use when they electronically submit IND safety reports that are required under 21 CFR 312.32(c)(1)(i)
FDA Policy/General
Federal Register notice: FDA is making available a draft guidance entitled “Animal Studies for Dental Bone Grafting Material Devices — Premarket Notification (510(k)) Submissions.” The document provides animal study design recommendations and information to include to support a 510(k) submission for dental bone grafting material devices. It is also
FDA Policy/General
On the heels of the U.S. Supreme Court’s 3/26 oral arguments in Danco Laboratories v. Alliance For Hippocratic Medicine that restricts distribution of the chemical abortion pill mifepristone (Danco’s Mifeprex), a new Axios/Ipsos poll finds that most Americans say they support FDA continuing to approve
FDA Policy/General
Federal Register notice: FDA is withdrawing approval of 30 abbreviated new drug applications from multiple applicants after they notified the agency that the affected drugs were no longer marketed and requested that their ANDAs be withdrawn. To view the notice, click here.
FDA Policy/General
Federal Register notice: FDA is announcing the over-the-counter Monograph Drug User Fee Program facility fee rates for fiscal year (FY) 2024. The notice includes information about facility fee calculations, fee due dates, and fee payment procedures. The FY 2024 facility fee rates are as follows: * Monograph Drug Facility
FDA Policy/General
FDA Office of Combination Products (OCP) associate director for policy John Weiner has been promoted to Office of Global Operations director, where he will oversee the agency’s foreign inspection offices, as well as its international policy advisors, who are responsible for bilateral and regional engagement. At OCP, FDA says
FDA Policy/General
Federal Register proposed rule: FDA is proposing to ban electrical stimulation devices intended for self-injurious behavior or aggressive behavior. The agency has determined that the devices present an unreasonable and substantial risk of illness or injury that cannot be corrected or eliminated by labeling. To view the notice, click
FDA Policy/General
Federal Register notice: FDA is making available a guidance entitled “Handling and Retention of BA and BE Testing Samples.” The document provides recommendations for NDA/ANDA application holders regarding the procedures for handling reserve samples from relevant bioavailability and bioequivalence studies. It also includes recommendations on the responsibilities of each