FDA Policy/General
Federal Register notice: FDA has announced a 5/14 Oncologic Drugs Advisory Committee meeting. In the morning session, the committee is scheduled to discuss a Daiichi Sankyo NDA for pexidartinib capsules, indicated for treating adult patients with symptomatic tenosynovial giant cell tumor. In the afternoon session, they will discuss Daiichi’
FDA Policy/General
Federal Register notice: FDA has announced a 5/7 Pharmaceutical Science and Clinical Pharmacology Advisory Committee meeting. Panel members are scheduled to discuss approaches to evaluate the effect of renal impairment on drug exposure, and best practice considerations for translating pharmacokinetic (PK) information into dose individualization instructions. To view the
FDA Policy/General
Federal Register notice: FDA has determined that Casper Pharma’s Antivert (meclizine hydrochloride) chewable tablets were not withdrawn from sale for reasons of safety or effectiveness. Antivert is indicated for treating vertigo associated with diseases affecting the vestibular system. The determination allows FDA to continue to approve ANDAs that refer
FDA Policy/General
Final Guide on REMS Factors Federal Register notice: FDA makes available a final guidance entitled “Risk Evaluation and Mitigation Strategy: FDA’s Application of Statutory Factors in Determining When a Risk Evaluation and Mitigation Strategy Is Necessary.” 04/05/2019 Cortisporin Not Withdrawn Due to Safety/Efficacy: FDA Federal Register
FDA Policy/General
Federal Register notice: FDA has made available a final guidance entitled “Risk Evaluation and Mitigation Strategy: FDA’s Application of Statutory Factors in Determining When a Risk Evaluation and Mitigation Strategy Is Necessary.” The document is intended to clarify how FDA applies factors in determining whether a risk evaluation and
FDA Policy/General
Federal Register notice: FDA determines that Monarch Pharmaceuticals’ Cortisporin (hydrocortisone/neomycin sulfate/polymyxin B sulfate) was not withdrawn from sale for reasons of safety or effectiveness. The determination allows FDA to approve ANDAs that reference the drug product as long as they meet relevant legal and regulatory requirements. Cortisporin is
FDA Policy/General
Federal Register notice: FDA has determined that Teva’s Qvar 40 and Qvar 80 (beclomethasone dipropionate HFA) inhalation aerosol products were not withdrawn from sale for reasons of safety or effectiveness. The determination will allow the agency to approve ANDAs that reference the products if all other legal and regulatory
FDA Policy/General
The Alliance for a Stronger FDA has submitted Congressional testimony that asks appropriators to increase President Trump’s FY 2020 budget proposal by 15% ($60 million) for an overall increase of $418 million. The $60 million boost should go towards food safety activities, the Alliance says, such as “enhanced funding
FDA Policy/General
Federal Register notice: FDA is proposing a new information collection on “Providing Regulatory Submissions in Electronic and Non-Electronic Format — Promotional Labeling and Advertising Materials for Human Prescription Drugs.” The collection is intended to support recommendations found in the same-titled agency guidance, which outlines the requirements and recommendations for
FDA Policy/General
Federal Register notice: FDA has announced a 5/31 public hearing to obtain scientific data and information about the safety, manufacturing, product quality, marketing, and labeling of products containing cannabis or cannabis-derived compounds. To view the notice, click here.
FDA Policy/General
Federal Register notice: FDA is seeking comments on an information collection extension related to its “Guidance: Emergency Use Authorization of Medical Products and Related Authorities” (OMB Control Number 0910-0595). The guidance describes the agency’s policies applicable to emergency use authorizations of the of certain medical products. It says
FDA Policy/General
Federal Register notice: FDA is seeking comments on an information collection extension related to a guidance entitled “Medical Device Accessories” (OMB Control Number 0910–0823). The document addresses the regulation of accessories to medical devices and describes FDA’s policy concerning the classification of accessories. It also describes the processes
FDA Policy/General
A Health Affairs article assesses FDA commissioner Scott Gottlieb’s nearly two years in office in terms of his efforts to advance policy in three areas relating to prescription drugs, and then looks ahead to how the agency may change under Ned Sharpless. The three drug policy areas considered are
FDA Policy/General
Outgoing FDA commissioner Scott Gottlieb, who was a resident fellow at the American Enterprise Institute (AEI) conservative think tank before being named to head FDA, is returning to AEI to focus on drug prices. In an interview with the Washington Post, Gottlieb said he is interested in trying to determine
FDA Policy/General
FDA has released 30 years of adverse event reports related to animal drugs and medical devices used in animals. The reports are available online here. An agency announcement of the release says the action “is part of a broader effort by the agency to increase the transparency and sharing of
FDA Policy/General
Federal Register notice: FDA has announced a 5/13 public hearing to discuss access to affordable insulin products and issues related to the development and approval of biosimilar and interchangeable insulin products. To view the notice, click here.
FDA Policy/General
Federal Register notice: FDA has determined that Bayer’s Chlor–Trimeton Allergy 12 Hour (chlorpheniramine maleate) extended release tablets 8mg and 12mg were not withdrawn from sale for reasons of safety or effectiveness. The determination means that FDA will continue to approve ANDAs that refer to the product as long
FDA Policy/General
Federal Register notice: FDA has determined that Lundbeck Pharmaceuticals’ Onfi (clobazam) tablets 5mg were not withdrawn from sale for reasons of safety or effectiveness. The determination will allow FDA to approve ANDAs that reference the drug product, if all other legal and regulatory requirements are met. To view the notice,
FDA Policy/General
Federal Register notice: FDA has announced the renewal of the Technical Electronic Product Radiation Safety Standards Committee for an additional two years beyond the charter expiration date. The new charter will be in effect until 12/24/2020. To view the notice, click here.
FDA Policy/General
Federal Register notice: FDA has announced the continuation of the Regulatory Project Management Site Tours and Regulatory Interaction Program. The agency is currently inviting pharmaceutical companies interested in participating in this program to contact CDER by 6/3. To view the notice, click here.
FDA Policy/General
Federal Register notice: FDA has issued a priority review voucher to Siga Technologies for gaining approval of a material threat medical countermeasure product application. In awarding the voucher, the agency determined that Siga’s NDA for TPoxx (tecovirimat), indicated to treat human smallpox disease in adults and pediatric patients weighing
FDA Policy/General
Federal Register notice: FDA is withdrawing approval of 16 NDAs from multiple applicants. The applicants notified the agency that the drug products were no longer marketed and requested that they be withdrawn. To view the notice, click here.