FDA Policy/General
Federal Register notice: FDA has submitted to OMB a new information collection entitled “Health Care Providers’ Understanding of Opioid Analgesic Abuse Deterrent Formulations (ADF).” FDA has determined that systematic research is necessary to provide detailed and comprehensive evidence on which to base the agency’s ADF-related policy, regulatory, and
FDA Policy/General
Federal Register notice: FDA is seeking comments on a proposed information collection entitled “Study of Disclosures to Health Care Providers Regarding Data That Do Not Support Unapproved Use of an Approved Prescription Drug.” The purpose of the research is to examine healthcare providers’ perceptions and behavioral intentions about an unapproved
FDA Policy/General
Federal Register notice: FDA is seeking comments on a proposed information collection entitled “Study of Multiple Indications in Direct-to-Consumer Television Advertisements.” The study is intended to provide preliminary information on whether consumers face challenges when multiple indications are promoted in a single television ad. It will also explore
FDA Policy/General
Federal Register notice: FDA has submitted to OMB a proposed information collection entitled “Healthcare Provider Perception of Boxed Warning Information Survey.” The collection is intended to investigate healthcare providers’ awareness, perceptions, and beliefs about the benefits and risks of an FDA-approved product that carries a boxed warning. It proposes
FDA Policy/General
Federal Register notice: FDA has determined that Mylan’s Zovirax (acyclovir) oral capsule, 200 mg, was not withdrawn from sale for reasons of safety or effectiveness. The determination allows the agency to continue to approve ANDAs that refer to the product as long as they meet relevant legal and regulatory
FDA Policy/General
Federal Register notice: FDA has submitted to OMB an information collection extension for “Radioactive Drug Research Committees — 21 CFR 361.1” (OMB Control Number 0910-0053). The collection supports regulations on radioactive drug research committees and their role in approving and monitoring basic research studies using radiopharmaceuticals. To view the
FDA Policy/General
Federal Register notice: FDA has withdrawn approval of Teva’s NDA for Zecuity (sumatriptan iontophoretic transdermal system) after the company requested its withdrawal. The drug was approved in 2013 for treating migraines, but in 2016 Teva suspended sales, marketing and distribution to investigate the cause of burns and scars associated
FDA Policy/General
A House appropriations subcommittee has approved by voice vote a bill that includes an additional $41 million for FDA in fiscal year 2021. The vote advances FDA’s budget totaling $3.212 billion in discretionary funding. Total funding for the agency, which includes user fees, is $5.99 billion. “Within
FDA Policy/General
FDA has posted its latest batch of Warning Letters. They can be accessed by clicking on the link following each letter. Greiner Bio-One, Monroe, NC (4/16): FDA inspected the firm 12/2019 and cited GMP violations for its medical device (Vacuette brand blood collection tubes). For example, Greiner
FDA Policy/General
Federal Register notice: FDA has made available a guidance entitled “Unique Device Identification: Policy Regarding Compliance Dates for Class 1 and Unclassified Devices and Certain Devices Requiring Direct Marking; Immediately in Effect Guidance for Industry and Food and Drug Administration Staff.” The document describes FDA’s intention with respect to
FDA Policy/General
Federal Register notice: FDA has made available a draft guidance entitled “Development of Anti-Infective Drug Products for the Pediatric Population.” The document addresses initiation of pediatric clinical studies, enrollment strategies, efficacy extrapolation, and other considerations to help facilitate pediatric anti-infective drug product development. To view the notice, click
FDA Policy/General
Federal Register notice: FDA has established a docket to solicit public comment on specific questions pertaining to the use of codeine for analgesia in children under 12 years of age, and the use of cytochrome P450 2D6 (CYP2D6) testing in children under 12 years of age prior to treatment with
FDA Policy/General
Federal Register notice: FDA has submitted to OMB an information collection extension for “Reporting Associated With Animal Drug and Animal Generic Drug User Fees” (OMB Control Numbers 0910-0540). The collection supports information associated with the Animal Drug User Fee cover sheet. To view the notice, click here.
FDA Policy/General
FDA has posted its latest batch of Warning Letters. They can be accessed by clicking on the link following each letter. Auro Pharmacies, La Habra, CA (6/3): FDA inspected the firm 7/2018 and cited serious deficiencies in its practices for producing sterile drug products. For example, FDA investigators
FDA Policy/General
Federal Register notice: FDA is seeking comments on an information collection extension for “Exceptions or Alternatives To Labeling Requirements for Products Held by the Strategic National Stockpile” (OMB Control Number 0910-0614). The collection addresses (XXX SUBSTITUTE XXX) when it may be appropriate for certain medical products held in the
Drugs
The Justice Department says Novartis will pay $678 million to the federal government and several states to settle a whistleblower’s civil fraud suit alleging that the company violated the False Claims Act and anti-kickback laws by providing doctors cash payments, recreational outings, lavish meals, and expensive alcohol to
FDA Policy/General
The CDER Office of Prescription Drug Promotion is proposing research to determine whether consumers face challenges when multiple indications are promoted in a single direct-to-consumer TV ad. A Federal Register notice says the study also will explore whether the similarity of the indications affects participants’ likelihood to recall
FDA Policy/General
Federal Register notice: FDA has announced a virtual public meeting entitled “Generic Drug User Fee Amendments (GDUFA) of 2017.” New legislation is required by 10/2022 for FDA to continue to collect generic drug user fees for future fiscal years. The meeting is intended to obtain public input on the
FDA Policy/General
Federal Register notice: FDA has made available guidance documents related to the Covid–19 public health emergency. The documents have been implemented without prior comment, but they remain open for comments under the agency’s good guidance practices. To view the notice, click here.
FDA Policy/General
In observance of the Fourth of July (Independence Day) holiday in the U.S., the news operations of FDA Webview are closed until Monday, July 6. The next overnight email news bulletin from this site will be issued that evening.
FDA Policy/General
Federal Register notice: FDA has made available a final guidance entitled “Community-Acquired Bacterial Pneumonia (CABP): Developing Drugs for Treatment.” The document clarifies the time to assess the primary efficacy endpoint (Day 4), updates to the CABP trial population based on the Pneumonia Patient Outcomes Research Team scores, evaluation of
FDA Policy/General
Federal Register notice: FDA is making available a final guidance entitled “Hospital-Acquired Bacterial Pneumonia and Ventilator-Associated Bacterial Pneumonia: Developing Drugs for Treatment.” The document includes updates to the intended trial population, randomization, prior antibacterial drug therapy, and analysis populations. To view the notice, click here.