FDA Policy/General
Federal Register notice: FDA has submitted to OMB an information collection revision entitled “Medical Device User Fee Cover Sheet, Form FDA 3601 and Device Facility User Fee Cover Sheet, Form FDA 3601a.” Form FDA 3601 is designed to provide the minimum necessary information to determine whether a fee is required
FDA Policy/General
Federal Register notice: FDA has submitted to OMB an information collection revision entitled “Export Certificates for FDA Regulated Products.” Regulatory provisions require the agency to issue written export certifications for medical devices within 20 days of a request. To offset the agency resource commitments, it may charge firms a fee
FDA Policy/General
Federal Register notice: FDA is issuing an order to reduce a five-year debarment against former Indivior global medical director Timothy Baxter. The agency says the debarment will now end 10/26/2025, three years earlier than originally ordered, due to a “mutual agreement of the parties.” The debarment was
FDA Policy/General
A lengthy Food & Drug Law Institute (FDLI) analysis shows how two fisheries cases before the Supreme Court could lead to major changes in the regulatory landscape for FDA and other federal agencies. The report says the high court appears poised to at least significantly modify, if not eliminate, the
FDA Policy/General
Former FDA associate chief counsel and CDER policy advisor Eva A. Temkin has joined Paul Hastings as chair of the firm’s FDA practice. She spent over eight years at the agency before leaving in 2021 to join King & Spaulding as a partner. In her new role, Temkin will
FDA Policy/General
Federal Register notice: FDA is amending its animal drug regulations to reflect application-related actions for new animal drug applications and abbreviated new animal drug applications during the fourth quarter of 2023. The regulations are also being amended to improve their accuracy and readability. To view the notice, click here.
FDA Policy/General
Federal Register notice: FDA has determined for patent extension purposes the regulatory review period for Janssen Biotech’s Rybrevant (amivantamab-vmjw), indicated for treating adult patients with locally advanced or metastatic non-small cell lung cancer with epidermal growth factor receptor exon 20 insertion mutations. The regulatory review period is
FDA Policy/General
Pharmaceutical Research and Manufacturers of America (PhRMA) says it is concerned that research proposed by the CDER Office of Prescription Drug Promotion (OPDP) on implied claims in direct-to-consumer (DTC) drug promotions “lacks practical utility.” The association’s comment letter says it is not clear what the agency intends
FDA Policy/General
Federal Register notice: FDA is making available a final guidance entitled “Assessing Covid–19-Related Symptoms in Outpatient Adult and Adolescent Subjects in Clinical Trials of Drugs and Biological Products for COVID–19 Prevention or Treatment.” The document is intended to provide sponsors and investigators with considerations for approaches on
FDA Policy/General
Federal Register notice: FDA is issuing an order debarring Taylor McLaren for five years from importing or offering for import any drug into the U.S. The action is based on his conviction of one felony count for conspiracy to smuggle prescription drugs into the U.S. To view the
FDA Policy/General
Federal Register notice: FDA is making available a draft guidance entitled “Select Updates for the Medical Device User Fee Small Business Qualification and Certification Guidance.” The document describes how FDA plans to determine if a small business is experiencing “financial hardship” which makes them eligible for a waiver of their
FDA Policy/General
Federal Register notice: FDA is amending its standing advisory committee regulations to add the new Digital Health Advisory Committee. The committee was established 10/2023 to provide advice on complex scientific and technical issues related to digital health technologies (DHTs). This also may include advice on the regulation of DHTs
FDA Policy/General
Federal Register notice: FDA is extending the comment period on a 12/22 notice for its “Master Protocols for Drug and Biological Product Development” draft guidance. The extension is based on requests from stakeholders requesting additional time to submit comments. To view the notice, click here.
FDA Policy/General
Federal Register notice: FDA is amending a 12/12/2023 notice requesting nominations for voting members to serve on CDER’s Genetic Metabolic Diseases Advisory Committee. The amendment says nominations received on or before 3/12 will be given first consideration for membership on the committee. To view the notice,
FDA Policy/General
Federal Register notice: FDA is making available additional draft and revised draft product-specific guidances that provide recommendations on, among other things, the design of bioequivalence studies to support ANDAs. To view the notice, click here.
Biologics
Speaking on 2/14 at the National Press Club, FDA commissioner Robert Califf challenged journalists to “continue striving for approaches that benefit public health in the best possible manner.” Saying he wanted to bring some Valentine’s Day “tough love” to the audience, Califf spoke on his pressing theme of
FDA Policy/General
Senators Dick Durbin (D-IL) and Mike Braun (R-IN) are calling on FDA to “take swift action to update its enforcement tools to reflect the current platforms and methods used to promote prescription drugs and biologics, and to prioritize the protection of children from harmful and inaccurate medical advice.
FDA Policy/General
Federal Register notice: FDA is making available a final guidance entitled “Charging for Investigational Drugs Under an IND: Questions and Answers.” The document addresses frequently asked questions related to FDA’s regulation on charging for investigational drugs used in clinical trials or an expanded access for treatment use request. To
FDA Policy/General
Federal Register notice: FDA is announcing that its Office of Digital Transformation has modified its organizational structure. The new structure was approved by HHS on 12/21/2023 and is intended to consolidate similar functions and resources across multiple areas and align them with federal and industry standards. To view
FDA Policy/General
Federal Register notice: FDA is announcing the continuation of its Regulatory Project Management Site Tours and Regulatory Interaction Program. The program provides agency regulatory project managers the opportunity to tour pharmaceutical facilities. The goals are to provide the following: (1) firsthand exposure to industry’s drug development processes and (2)
FDA Policy/General
FDA’s Medical Devices Advisory Committee Circulatory System Devices Panel has voted 13 to 1 that the benefits of Abbott's TriClip transcatheter edge-to-edge repair system outweighs the risks for the treatment of people with tricuspid regurgitation (TR). An FDA briefing document said the pivotal trial’s
FDA Policy/General
The FDA Office of Digital Transformation (ODT) has posted the FDA Information Technology (IT) Operating Plan, described as a “milestone in the agency’s technological evolution.” An online post (contains a link to the plan) says the plan sets forth strategies and initiatives to enhance service delivery to the public.