FDA Related News

FDA General

Latest Federal Register Notices

FDA Review posts the Federal Register notices for the week ending 5/31/2019.

FDA General

Since Our Last Issue ...

Industry news you may have missed since our last issue.

FDA General

Product Approval Summaries

FDA Review posts product approval summaries for the week ending 5/31/2019.

Federal Register

Info Collection Extension on Supplement Notifications

Federal Register notice: FDA submits to OMB an information collection extension entitled Food Labeling; Notification Procedures for Statements on Diet...

Federal Register

Comments Sought on Opioid Unit-of-Use Packaging

Federal Register notice: FDA seeks public comments on a potential modification to the Opioid Analgesic Risk Evaluation and Mitigation Strategy to requ...

Federal Register

Study Risk-Based Monitoring Approaches Workshop

Federal Register notice: FDA announces a 7/17 public workshop entitled Improving the Implementation of Risk-Based Monitoring Approaches of Clinical In...

FDA Promo Violation Letter on Qsymia Web Page

CDERs Office of Prescription Drug Promotion issues Vivus an untitled letter over false and misleading claims made on its Web page for weight-loss drug...

Human Drugs

Cough Syrup Recalled Due to Label Typo Error

Novis PR recalls five lots of PexGen DMX, 16 oz, liquid cough syrup due to incorrect dosage information on its label due to a typographical error.

Human Drugs

FDA and COTA Ink Breast Cancer Research Pact

FDA and precision medicine technology company COTA, Inc. collaborate to establish a real-world evidence study protocol with an initial focus on breast...

FDA General

FDA Cannabis Hearing Probes Regulatory Issues

FDA kicks off a long-awaited public hearing on cannabis-derived products by placing emphasis on ensuring marketers do not make drug-like claims, while...