FDA Policy/General
Federal Register notice: FDA is seeking comments on an information collection extension entitled “Rapid Response Surveys” (OMB Control Number 0910-0500). The collection supports these surveys FDA conducts to determine whether a problem impacts the public health and to quickly obtain vital information about risks and interventions. Participation in the
FDA Policy/General
Federal Register notice: FDA is announcing it is revoking the emergency use authorizations (EUAs) issued to BioFire Defense for the FilmArray NGDS BT‐E Assay, and Biocartis for the Idylla Rapid Ebola Virus Triage Test. The companies said the Ebola tests are no longer commercially available and requested that their
FDA Policy/General
The U.S. Supreme Court 4/19 extended by two days its administrative stay of a lower court’s 4/7 order (see earlier story) that would restrict the distribution of the abortion drug mifepristone. The additional stay until 11:59 PM 4/21 gives the high court additional time
FDA Policy/General
FDA has granted traditional approval to Genentech’s Polivy (polatuzumab vedotin-piiq) for combination use with Rituxan (rituximab), cyclophosphamide, doxorubicin and prednisone (R-CHP) for treating certain adult patients who have previously untreated diffuse large B-cell lymphoma (DLBCL). Previously the drug was available under accelerated approval in combination with
FDA Policy/General
House Committee on Oversight and Accountability chairman James Comer (R-KY) is putting pressure on FDA over its late January claim that it could not regulate cannabidiol (CBD) products as dietary supplements (see earlier story). Comer sent a 4/14 letter to Robert Califf saying his committee is investigating the
FDA Policy/General
Federal Register notice: FDA has announced an opportunity for public comments on an information collection extension entitled “FDA Human Cells, Tissues, and Cellular and Tissue-Based Products — 21 CFR Part 1271.” The collection helps support the implementation of statutory and regulatory requirements that govern certain human cells, tissues, and cellular
FDA Policy/General
Federal Register notice: FDA is correcting a 4/11 notice entitled “Vaccines and Related Biological Products Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for Comments” that contained an incorrect docket number. This is now corrected to reflect Docket No. FDA-2023-N-1338. To view the
Drugs
Researchers from FDA and RTI International say data displays in prescription drug advertising geared to healthcare providers are often “highly complex.” Writing in Therapeutic Innovation & Regulatory Science, the researchers say information conveyed in prescription drug promotion data displays vary in their presentation and complexity. The study characterized the content
FDA Policy/General
Federal Register notice: FDA is announcing a 6/7-8 public workshop entitled “Rare Disease Endpoint Advancement Pilot Program Workshop: Novel Endpoints for Rare Disease Drug Development.” The workshop is being conducted by the Duke-Robert J. Margolis, MD Center for Health Policy under a cooperative agreement. Meeting sessions will
FDA Policy/General
Federal Register notice: FDA is announcing the issuance of an emergency use authorization (EUA) to Cue Health for the Cue Mpox (Monkeypox) Molecular Test. The EUA is based on HHS’ 8/9/2022 determination that there is a public health emergency related to the monkeypox virus and the need for
FDA Policy/General
After 15 years at the agency, FDA associate commissioner for regulatory affairs Judith McMeekin has announced her retirement effective 6/30 – with many below her to follow suit thereafter. Speaking at a 4/14 Alliance for a Stronger FDA budget update, McMeekin said her deputy Carol Cave will serve as
FDA Policy/General
Federal Register notice: FDA has made available a revised draft guidance “Assessing Adhesion With Transdermal and Topical Delivery Systems for ANDAs.” The document, which revises a 2018 draft guidance under the same title, provides recommendations for designing and conducting studies evaluating the adhesion performance of a transdermal or topical delivery
FDA Policy/General
Federal Register notice: FDA has made available a final guidance entitled “Peripheral Percutaneous Transluminal Angioplasty (PTA) and Specialty Catheters — Premarket Notification (510(k)) Submissions.” The submission recommendations apply to PTA balloons and specialty catheters (e.g., infusion catheters, PTA balloon catheters for in-stent restenosis, scoring/cutting balloons). To view
FDA Policy/General
Federal Register notice: FDA is making available a draft guidance entitled “Over-the-Counter Monograph Order Requests (OMORs): Format and Content.” The document provides recommendations on the information that a requestor should provide in an OMOR and identifies relevant guidance documents to assist requestors in preparing their submissions. To view
FDA Policy/General
Federal Register notice: FDA is announcing a request for information and comments on the development of an FDA data and technology strategic plan. Under the user fee program commitments, FDA is required to develop and publish by 9/30 its strategic plan, which is intended to define and shape the
FDA Policy/General
Federal Register notice: FDA has issued a final order to exempt certain categories of biological products from annual reporting requirements under the Federal Food, Drug, and Cosmetic Act as amended by the Coronavirus Aid, Relief, and Economic Security Act. Biologic makers are required to report to FDA the amount of
FDA Policy/General
Federal Register notice: FDA is making available a final guidance entitled “A Risk- Based Approach to Monitoring of Clinical Investigations — Questions and Answers.” The document provides risk-based approaches for monitoring drug, biologic and medical device investigational studies. It also contains recommendations on planning a monitoring approach, developing the content
FDA Policy/General
Federal Register notice: CDRH has announced its Radiation Sterilization Master File Pilot Program, a voluntary program intended to allow companies that terminally sterilize single-use medical devices using gamma radiation or ethylene oxide to submit Master Files when making certain changes to sterilization sites, methods, or processes under the specific
FDA Policy/General
Federal Register notice: FDA has announced a 6/8 public meeting entitled “Financial Transparency and Efficiency of the Prescription Drug User Fee Act, Biosimilar User Fee Act, and Generic Drug User Fee Amendments.” It will provide an update on topics related to the financial management of the drug, biosimilar, and
FDA Policy/General
Federal Register notice: FDA is seeking comments on an information collection revision entitled “Generic Drug User Fee Program; Controlled Correspondence.” The collection is being revised to include recommendations found in agency guidance that discusses the process by which generic drug manufacturers and related industry or their representatives can request information
FDA Policy/General
Federal Register notice: FDA is seeking comments on an information collection revision entitled “Medical Devices; Reports of Corrections and Removals — 21 CFR Part 806.” The collection supports an agency regulation requiring device manufacturers and importers to promptly report certain actions concerning device corrections and removals and to maintain associated records.
FDA Policy/General
Federal Register notice: FDA is seeking comments on an information collection revision entitled “Investigational New Drug Application Requirements.” The collection is being revised to include burden that may be associated with recommendations found in the guidance document entitled “E6(R2) Good Clinical Practice: Integrated Addendum to ICH E6(R1) (March