FDA Policy/General
FDA says that the most important enhancements in the Prescription Drug User Fee Act (PDUFA VII) reauthorization are a new early interaction meeting for getting feedback on development programs, a new program on drug supplemental submissions, and increased staffing to address the increasing review obligations of cell and gene therapy
FDA Policy/General
FDA has named Kimberlee Trzeciak, the chief health advisor for the House Energy and Commerce Committee, as the agency’s associate commissioner for legislative affairs. Committee chairman Frank Pallone (D-NJ) praised the hire, saying Trzeciak was one of the committee’s first hires when he became ranking member in
FDA Policy/General
Federal Register notice: FDA is withdrawing approval of 29 NDAs from multiple applicants after they notified the agency that the drug products were no longer marketed and requested that they be withdrawn. To view the notice, click here.
FDA Policy/General
Federal Register notice: FDA is withdrawing approval of eight ANDAs from multiple applicants after they notified the agency that the drug products were no longer marketed and requested their withdrawal. To view the notice, click here.
FDA Policy/General
Federal Register notice: FDA has made available a final guidance entitled “Principles of Premarket Pathways for Combination Products.” The document outlines FDA’s current thinking on principles for premarket review of combination products. It includes general, high-level information regarding what combination products are, coordination within FDA and agency/sponsor
FDA Policy/General
Federal Register notice: FDA is renewing for an additional two years its Vaccines and Related Biological Products Advisory Committee. The new charter will be in effect until 12/31/2023. To view the notice, click here.
FDA Policy/General
Presumably in a move to secure Senate support for his nomination, FDA commissioner nominee Robert Califf has agreed to significant ethics commitments. In a 1/27 letter to Senator Elizabeth Warren (D-MA), Califf committed to recuse himself from matters involving his former employers and clients for four years — two
FDA Policy/General
BIOLOGICS FDA has approved an Amgen BLA for Imlygic (talimogene laherparepvec), a genetically modified oncolytic viral therapy indicated for the local treatment of unresectable cutaneous, subcutaneous and nodal lesions in patients with melanoma recurrent after initial surgery. The company says that the drug has not been shown to improve overall
FDA Policy/General
Boston Scientific signed a temporary agreement with C.R. Bard to begin selling a Lutonix drug-coated inflatable balloon, which received FDA approval last October to re-open arteries in the thigh and knee when they are blocked as a result of peripheral artery disease. The device would compete with
FDA Policy/General
Federal Register notice: FDA is extending the comment period for a 12/23 notice on a draft guidance entitled “Assessing the Credibility of Computational Modeling and Simulation in Medical Device Submissions.” Comments should now be submitted by 3/4. To view the notice, click here.
FDA Policy/General
Federal Register notice: FDA has submitted to OMB an information collection extension entitled “Generic Clearance for Quantitative Testing for the Development of FDA Communications” (OMB Control Number 0910-0865). The collection covers FDA’s use of quantitative social/behavioral science data collection techniques (i.e., surveys and experimental studies) to
FDA Policy/General
The House Energy and Commerce Committee’s Health Subcommittee is holding a user fee reauthorization hearing 2/3 at 10:30 a.m. The hearing will review the reauthorization legislative language for the Biosimilar User Fee Amendments of 2022, Generic Drug User Fee Amendments of 2022, and Prescription Drug User
FDA Policy/General
Federal Register notice: FDA is seeking comments on an information collection extension entitled “Export of Medical Devices; Foreign Letters of Approval” (OMB Control Number 0910-0264). Section 801(e)(2) of the Federal Food, Drug, and Cosmetic Act provides for the exportation of an unapproved device under certain circumstances. The
FDA Policy/General
Federal Register notice: FDA is announcing the availability of its annual compilation of update notices related to the agency’s “Susceptibility Test Interpretive Criteria” Web page. FDA is publishing this notice in accordance with procedures established by the 21st Century Cures Act. The act clarified that sponsors of antimicrobial susceptibility
FDA Policy/General
FDA commissioner nominee Robert Califf is reportedly losing Senate backing and the White House has been slow to help advance his confirmation standing. Five Democrats — Sens. Bernie Sanders (I-VT), Joe Manchin (D-WV), Ed Markey (D-MA.), Maggie Hassan (D-NH) and Richard Blumenthal (D-CT) — have signaled opposition
FDA Policy/General
Federal Register notice: FDA is making available a draft guidance entitled “Revising ANDA Labeling Following Revision of the RLD Labeling.” This guidance provides recommendations for updating ANDA labeling following revisions to the reference-listed drug (RLD) labeling, including information on how to identify RLD labeling updates and how to submit
FDA Policy/General
Federal Register notice: FDA is making available a final guidance entitled “Information Requests and Discipline Review Letters Under GDUFA.” The document explains how FDA will issue and use an information request and discipline review letter during the assessment of an original ANDA. To view the notice, click here.
FDA Policy/General
Federal Register notice: FDA has announced a 4/12 virtual public meeting entitled “Prescription Drug User Fee Act of 2017; Electronic Submissions and Data Standards.” The meeting fulfills FDA’s commitment to seek stakeholder input related to data standards and the electronic submission system’s past performance, future targets, emerging
FDA Policy/General
Federal Register notice: FDA has evaluated certain substances that have been nominated for inclusion on a list of bulk drug substances (i.e., active pharmaceutical ingredients) for which there is a clinical need (the 503B Bulks List). Drug products that outsourcing facilities compound using bulk drug substances on the 503B
FDA Policy/General
Former FDA deputy commissioner for medical and scientific affairs Anand Shah has joined Big Health’s board of directors. Shah is being asked to help expand access to digital therapeutics as non-drug alternatives for mental health care, the company says, adding that he will take an active role in
FDA Policy/General
Law firm Hogan Lovells has added former FDA investigator Chris Middendorf as the firm’s regulatory affairs director. In this capacity, Middendorf will assist life sciences clients with regulatory and policy issues, such as product quality and manufacturing issues, and related compliance with FDA requirements for pharmaceuticals and biological products.
FDA Policy/General
Federal Register notice: FDA has made available a final guidance entitled “Good ANDA Submission Practices.” The document highlights common, recurring deficiencies that may lead to an ANDA approval delay. It also makes recommendations to applicants on how to avoid the deficiencies and minimize the number of review cycles. To view