Drugs
Two Sheppard Mullin attorneys say a recent untitled letter to Bristol Myers Squibb’s Mirati unit involving communications to healthcare providers on its Krazati (adagrasib) tablets that received accelerated approval to treat some lung cancers is a “cautionary tale to sponsors of accelerated approval drugs.” Writing online in a National
FDA Policy/General
Gardner Law attorneys say FDA is receiving pressure from Congress and the medical community to increase its oversight of online prescription drug advertising. In an online post, Gardner says there is increasing concern about social influencers promoting the drugs without adequately disclosing their risks. The post reviews a Law.com
FDA Policy/General
Federal Register notice: FDA is seeking comments by 8/23 on the abuse potential, actual abuse, medical usefulness, trafficking, and impact of scheduling changes on medical use availability for eight drug substances. The comments will be considered in preparing a response to the World Health Organization about the abuse liability
FDA Policy/General
Federal Register notice: FDA is announcing a 10/7 Science Board Advisory Committee meeting that will hear an update from the new Alternative Methods Subcommittee. The agency says its alternative methods initiative has the potential to provide more timely and predictive information to assess certain aspects of FDA-regulated products
FDA Policy/General
Federal Register notice: The FDA is announcing the renewal of its Peripheral and Central Nervous System Drugs advisory committee for an additional two years. The new charter will be in effect until 6/4/2026. To view the notice, click here.
FDA Policy/General
As a follow-up to an FDA 6/13 public listening session on the agency’s use of and procedures for advisory committees, 3D Communications surveyed more than 400 current and former advisory committee members so their voices could be part of the conversation. The firm said the listening session
FDA Policy/General
Federal Register notice: FDA is announcing a 9/13 Gastrointestinal Drugs Advisory Committee meeting to discuss an Intercept Pharmaceuticals supplemental NDA for Ocaliva (obeticholic acid) that was filed to fulfill its 2016 accelerated approval postmarketing requirements. The submission includes data describing and verifying clinical benefit for treating adult patients with
FDA Policy/General
Federal Register notice: FDA is announcing a 10/16 public meeting entitled “Advancing Rare Disease Therapies Through an FDA Rare Disease Innovation Hub.” The meeting is intended to outline the new hub, which it says will enhance collaboration and cooperation among CBER, CDER, and other offices to advance rare disease
FDA Policy/General
Federal Register notice: FDA is withdrawing an 8/2 notice that sought comments on a proposed information collection entitled “Risk/Safety Considerations and Motivations for Purchase and Use of Kratom and Psychedelics Alone and in Combination With Other Substances.” At the time, the agency said the collection was intended to
FDA Policy/General
Federal Register notice: FDA is making available a final guidance entitled “Optimizing the Dosage of Human Prescription Drugs and Biological Products for the Treatment of Oncologic Diseases.” The guidance is intended to assist sponsors in determining an optimized dosage for drugs/biologics used in treating oncologic diseases. The document does
FDA Policy/General
Federal Register notice: FDA is making available a draft guidance entitled “Bacillus Calmette-Guérin-Unresponsive Nonmuscle Invasive Bladder Cancer: Developing Drug and Biological Products for Treatment.’’ The purpose of this guidance is to assist sponsors in the development of drug and biological products for treating patients with bacillus Calmette-Guérin
FDA Policy/General
Federal Register notice: FDA is announcing an 11/19 joint meeting of its Drug Safety and Risk Management Advisory Committee and the Psychopharmacologic Drugs Advisory Committee. Panel members are scheduled to discuss a reevaluation of the clozapine risk evaluation and mitigation strategy and potential changes to reduce the burden on
FDA Policy/General
Federal Register notice: FDA has determined that Bayer’s Cipro (ciprofloxacin HCl) tablet, equivalent to 100 mg base, was withdrawn from sale due to safety or effectiveness reasons. The determination means the agency will not accept or approve ANDAs that reference the product. FDA says the drug’s effectiveness for
FDA Policy/General
Federal Register notice: FDA is announcing its fiscal year 2025 CDER Office of Pharmaceutical Quality (OPQ) Experiential Learning Site Visit Program. Beginning 10/1, drug companies are invited to submit a site visit proposal to CDER’s OPQ. The program is intended to provide first-hand learning opportunities that will
FDA Policy/General
Federal Register notice: FDA is announcing a 9/9 Antimicrobial Drugs Advisory Committee meeting to discuss an Iterum Therapeutics NDA for oral sulopenem etzadroxil/probenecid tablets for the proposed indication of treating uncomplicated urinary tract infections caused by designated susceptible bacteria in adult women 18 years of age and older.
FDA Policy/General
Federal Register notice: FDA is reopening the comment period for its proposed administrative order entitled “Amending Over-the-Counter Monograph M013: Internal Analgesic, Antipyretic, and Antirheumatic Drug Products for Over-the-Counter Human Use,” which was announced in a 6/14 Federal Register notice. The agency says it is reopening
FDA Policy/General
The CDER Office of Prescription Drug Promotion (OPDP) plans to survey some 2,400 healthcare providers on topics relating to prescription drug promotion. A Federal Register notice says topics to be surveyed include provider use of the Bad Ad program, understanding of quantitative data displays that may appear in prescription
FDA Policy/General
A Spark Biomedical petition asks FDA to enforce proper regulation of “wellness” devices. Spark markets the FDA-approved Sparrow transcutaneous auricular neurostimulation system. The petition specifically asks that FDA: * ensure that all neurostimulation wellness products claiming to “cure” or “treat” medical conditions are subject to the same regulatory standards as
FDA Policy/General
The CDER Office of Prescription Drug Promotion (OPDP) says a Web page targeting providers with information on the efficacy of Mirati Therapeutics’ Krazati (adagrasib) tablets, for oral use, as shown in the KRYSTAL-1 trial, makes false or misleading claims about the drug’s benefits. An 8/1 untitled letter
FDA Policy/General
Federal Register notice: FDA is announcing a 9/6 public workshop entitled “Enhancing Diversity in Therapeutics Development for Pediatric Patients” to discuss strategies to increase the enrollment of underrepresented populations in pediatric clinical trials and to help improve the strength and generalizability of the evidence for the intended use population.
FDA Policy/General
Federal Register notice: FDA is announcing the renewal of the Anesthetic and Analgesic Drug Products Advisory Committee for an additional two years beyond the charter expiration date. The new charter will be in effect until 5/1/2026. To view the notice, click here.
FDA Policy/General
Federal Register notice: FDA is making available a final guidance entitled “M12 Drug Interaction Studies” and the supplemental document entitled “M12 Drug Interaction Studies: Questions and Answers.” The International Council for Harmonization-prepared main document provides general recommendations on evaluating the enzyme and transporter- mediated pharmacokinetic drug-drug interaction potential