FDA Policy/General
FDA has posted a final guidance entitled “Alternative Procedures for the Manufacture of Cold-Stored Platelets Intended for the Treatment of Active Bleeding when Conventional Platelets Are Not Available or Their Use Is Not Practical.” The document is intended to provide a notice of exceptions and alternatives to certain requirements
FDA Policy/General
Federal Register notice: FDA is making available a draft guidance entitled “Formal Dispute Resolution and Administrative Hearings of Final Administrative Orders Under Section 505G of the Federal Food, Drug, and Cosmetic Act.” The document provides recommendations on the formal dispute resolution and administrative hearings procedures for resolving scientific and medical
FDA Policy/General
Federal Register notice: FDA is announcing the renewal of the Medical Imaging Drugs Advisory Committee for an additional two years beyond the charter expiration date. The new charter will be in effect until 5/18 2025. To view the notice, click here.
FDA Policy/General
Federal Register notice: FDA is making available a final guidance entitled “Oncology Drug Products Used with Certain In Vitro Diagnostic Tests: Pilot Program.” The document discusses the agency’s intention to pilot a new approach to provide greater transparency on performance characteristics that certain tests for oncology biomarkers should meet.
FDA Policy/General
Federal Register notice: FDA has issued an order permanently debarring Daylen Diaz from providing services in any capacity to a person that has an approved or pending drug product application. FDA based the order on Diaz’s felony conviction related to her role as a research assistant and assistant study
FDA Policy/General
Federal Register notice: FDA has announced a meeting of the Medical Devices Advisory Committee’s Circulatory System Devices Panel on 8/22/23. On 8/22, members will discuss and vote on a ReCor PMA for its Paradise Ultrasound Renal Denervation System, indicated for reducing blood pressure in adult patients
FDA Policy/General
FDA has posted a CVM guidance entitled “#171 Demonstrating Bioequivalence for Soluble Powder Oral Dosage Form Products and Type A Medicated Articles Containing Active Pharmaceutical Ingredients Considered to Be Soluble in Aqueous Media.” The document discusses how CVM intends to evaluate requests for waiving the requirement for performing in vivo
FDA Policy/General
Federal Register notice: FDA is making available a final guidance entitled “Content of Premarket Submissions for Device Software Functions.” The document provides information about the recommended documentation sponsors should include in premarket submissions for device software functions. To view the notice, click here.
Drugs
The CDER Office of Prescription Drug Promotion (OPDP) says pages at the Xeris Recorlev Web site make false or misleading claims and representations about the safety and efficacy of Recorlev (levoketoconazole) tablets, oral. A 6/7 Notice of Violation says the violations “are especially concerning from a public health perspective
FDA Policy/General
Federal Register notice: FDA is issuing an order to debar Luis Anarbol Moran for five years from importing any drug into the U.S. The agency bases this on a finding that Moran was convicted of one felony count. To view the notice, click here.
FDA Policy/General
Federal Register notice: FDA is seeking comments on an information collection extension entitled “Orphan Drugs — 21 CFR Part 316.” The collection supports FDA regulations that outline requirements for obtaining approval of an orphan drug and the conditions for obtaining seven-year exclusivity for such products. To view the notice, click
FDA Policy/General
The Biotechnology Innovation Organization (BIO) says it applauds FDA efforts to embark on a data and technology modernization strategy consistent with PDUFA 7 commitments and FY 2023 Omnibus Bill requirements. “BIO encourages FDA to think strategically and would welcome opportunities to provide feedback as FDA’s strategy evolves,” the association
FDA Policy/General
Federal Register notice: FDA has submitted to OMB an information collection extension entitled “Adverse Event Program for Medical Devices (Medical Product Safety Network (MedSun)). The collection supports FDA regulation requiring manufacturers and user facilities to report medical device-related deaths, serious injuries, and malfunctions. To view the notice, click here.
FDA Policy/General
Federal Register notice: FDA has submitted to OMB an information collection revision entitled “Premarket Notification of Devices.” The agency is revising the collection to include Form FDA 3674, “Certification of Compliance, Under 42 U.S.C., 282(j)(5)(B), with Requirements of ClinicalTrials.gov.” It is also being revised
FDA Policy/General
Federal Register notice: FDA is seeking comments on an information collection extension entitled “Allegations of Regulatory Misconduct Voluntarily Submitted to the Center for Devices and Radiological Health.” The collection supports the voluntary submission of such allegations to help FDA identify potential risks to patients and determine whether further investigation is
FDA Policy/General
FDA needs new policies geared toward integrating artificial intelligence (AI) into drug and medical product development, according to former FDA commissioner Scott Gottlieb and his former chief of staff Lauren Silvis. Writing in the 6/8 online JAMA Forum, they say that integrating AI “technologies into the current regulatory frameworks
FDA Policy/General
Federal Register notice: FDA is making available a final guidance entitled “Clinical Drug Interaction Studies With Combined Oral Contraceptives.” The document is intended to help drug sponsors evaluate whether they need drug-drug interaction studies with combined oral contraceptives (COCs). It also covers the design of such studies, how to
FDA Policy/General
Federal Register notice: FDA is announcing the renewal of its Dermatologic and Ophthalmic Drugs Advisory Committee for an additional two years beyond the charter expiration date. The new charter will be in effect until 10/7/2024. To view the notice, click here.
FDA Policy/General
Federal Register notice: FDA is issuing an order to permanently debar Analay Rico from providing services in any capacity related to an approved or pending drug product application. FDA bases the order on Rico’s 8/2022 guilty plea related to her role as a clinical research coordinator at Tellus
FDA Policy/General
Federal Register notice: FDA has determined that Bristol Myers Squibb’s Buspar (buspirone HCl) was not withdrawn due to safety or effectiveness reasons. The determination will allow FDA to approve ANDAs that reference the product if all other legal and regulatory requirements are met. Buspar was originally approved 12/2000
FDA Policy/General
Federal Register notice: FDA is seeking comments on an information collection extension entitled “Importation of Prescription Drugs — 21 CFR Part 251.” The collection supports implementation of Section 804 of the Federal Food, Drug, and Cosmetic Act, which is intended to reduce the cost of covered products to American consumers without
FDA Policy/General
Federal Register notice: FDA is announcing the renewal of the Antimicrobial Drugs Advisory Committee for an additional two years beyond the charter expiration date. The new charter will be in effect until 10/7/2024. To view the notice, click here.