FDA Policy/General
Federal Register notice: FDA has made available a final guidance entitled FDARA Implementation Guidance for Pediatric Studies of Molecularly Targeted Oncology Drugs. The document addresses early planning for pediatric evaluation of certain molecularly targeted oncology drugs and biological products. FDA says the early pediatric evaluation of certain molecularly targeted oncology
FDA Policy/General
The Pew Charitable Trusts says an FDA concept paper, Potential Approach for Defining Durations of Use for Medically Important Antimicrobial Drugs Intended for Use In or On Feed: A Concept Paper, “is substantially flawed and will require significant revision.” In a just-released 4/12 comment letter, Pew says the
FDA Policy/General
Federal Register notice: FDA has announced a 6/10 Vaccines and Related Biological Products Advisory Committee meeting. Panel members are scheduled to discuss, in general, data needed to support authorization and licensure of Covid–19 vaccines for use in pediatric populations. To view the notice, click here.
FDA Policy/General
Federal Register notice: FDA has announced a 7/15 Cardiovascular and Renal Drugs Advisory Committee meeting. Panel members are scheduled to review a FibroGen NDA for roxadustat, a hypoxia inducible factor prolyl hydroxylase inhibitor for treating anemia due to chronic kidney disease in adult patients on or not on dialysis.
FDA Policy/General
Federal Register notice: FDA has made available a final guidance entitled Enforcement Policy Regarding Use of National Health Related Item Code and National Drug Code Numbers on Device Labels and Packages. The document extends to 9/24/2023 the enforcement discretion date by which the agency does not intend to
FDA Policy/General
Federal Register notice: FDA has made available a final guidance entitled Demonstrating Bioequivalence for Soluble Powder Oral Dosage Form Products and Type A Medicated Articles Containing Active Pharmaceutical Ingredients Considered To Be Soluble in Aqueous Media. The document describes how the agency intends to evaluate requests for waiving the requirement
FDA Policy/General
Federal Register notice: FDA has made available a draft guidance entitled “Adjusting for Covariates in Randomized Clinical Trials for Drugs and Biological Products.” The document provides recommendations for covariate adjustment using nonlinear models. To view the notice, click here.
FDA Policy/General
Peripheral Vascular Atherectomy Devices 5/21/2021 Federal Register notice: FDA has made available a final guidance entitled Peripheral Vascular Atherectomy Devices — Premarket Notification Submissions. The document provides updated recommendations for premarket submissions for a new or modified peripheral vascular atherectomy device. To view the notice, click here. More ANDA-
FDA Policy/General
Federal Register notice: FDA has made available additional draft and revised draft product-specific guidances (XXX DELETE XXX)on, among other things, the design of bioequivalence studies to support ANDAs. To view the notice, click here.
FDA Policy/General
Federal Register notice: FDA has made available a final guidance on Testing and Labeling Medical Devices for Safety in the Magnetic Resonance (MR) Environment. It provides recommendations on the testing needed for assessing the safety and compatibility of medical devices in the magnetic resonance environment and the recommended format for
FDA Policy/General
Federal Register notice: FDA has made available a final guidance entitled Peripheral Vascular Atherectomy Devices — Premarket Notification Submissions. The document provides updated recommendations for premarket submissions for a new or modified peripheral vascular atherectomy device. To view the notice, click here.
FDA Policy/General
Federal Register notice: FDA has made available a final guidance entitled ANDAs for Certain Highly Purified Synthetic Peptide Drug Products That Refer to Listed Drugs of rDNA Origin. The document is intended to help potential applicants in determining when an application for a synthetic peptide drug product that refers to
FDA Policy/General
Federal Register notice: FDA has made available a draft guidance entitled Feasibility and Early Feasibility Clinical Studies for Certain Medical Devices Intended to Therapeutically Improve Glycemic Control in Patients with Type 2 Diabetes Mellitus. The document provides recommendations for feasibility and early feasibility clinical studies for certain medical devices intended
FDA Policy/General
Federal Register notice: FDA has made available a final guidance entitled Implanted Brain-Computer Interface (BCI) Devices for Patients with Paralysis or Amputation — Non-Clinical Testing and Clinical Considerations. The agency defines implanted brain-computer interface devices as neuroprostheses that interface with the central or peripheral nervous system to restore
FDA Policy/General
Federal Register notice: FDA has made available a draft information sheet guidance for sponsors, clinical investigators, and institutional review boards entitled Frequently Asked Questions — Statement of Investigator (Form FDA 1572) (Revision 1). The document explains FDA’s current thinking on waivers of the signature requirement for Form FDA 1572. To
FDA Policy/General
The Critical Path Institute (C-Path) has named former FDA commissioner Robert Califf to its board of directors. Califf was commissioner 2016-2017. A C-Path announcement says he currently is head of clinical policy and strategy for Google parent company Alphabet’s Verily Life Sciences and Google Health units.
FDA Policy/General
Federal Register notice: FDA has announced a 6/18 public meeting entitled “FDA Public Meeting on Financial Efficiency of Human Drug User Fee Programs.” The meeting will discuss financial transparency and efficiency of the Prescription Drug User Fee Act, the Biosimilar User Fee Act, and Generic Drug User Fee Amendments.
FDA Policy/General
FDA’s recently announced FDA Inspectional Affairs Council (FIAC), which will help plan and coordinate inspectional activities, is also intended to optimize the agency’s inspection program on an enterprise level, according to FDA associate commissioner for regulatory affairs Judy McMeekin. Delivering a keynote presentation at the Food and Drug
FDA Policy/General
FDA’s Office of Medical Policy clinical methodologies group has received a $9.2 million HHS grant to fund expansion of the CURE ID platform to allow automated data collection from electronic health records worldwide and clinical disease registries for Covid-19 and other difficult-to-treat infectious diseases. An
FDA Policy/General
Federal Register notice: FDA is publishing a list of five information collections that have been approved by the Office of Management and Budget. They are: * Empirical Study of Promotional Implications of Proprietary Prescription Drug Names (0910-0896) * Adverse Experience Reporting for Licensed Biological Products; and General Records (0910-0308) * Export
FDA Policy/General
As the U.S. continues to recover from the Covid-19 health emergency, FDA acting commissioner Janet Woodcock says the agency is at a critical inflection point and will begin to “more closely examine our response to this crisis, gauge what does work and formulate and implement plans to effectively
FDA Policy/General
Federal Register notice: FDA has determined that Adams Technologies’ Isoptin (verapamil hydrochloride) tablets (40mg, (XXX INSEDRT SPACE AFTER COMMA XXX)80mg and 120mg) and Pfizer’s Calan (verapamil hydrochloride) tablets (40mg, 80mg, 120mg and 160mg) were not withdrawn due to safety or effectiveness reasons. The determinations permit FDA to approve