This edition of Quick Notes includes EU approval of Pfizer’s hemophilia B gene therapy Durveqtix, a positive EMA opinion on an expanded label for Wegovy, two new EMA draft guidelines…

A Baxter Healthcare drug manufacturing plant in Marion, N.C., has been hit with another Form 483 after an FDA inspection early in the year revealed more deficiencies, including two that…

Immediately after the FDA rejected Novartis’s 2022 citizen petition for the agency to refrain from approving generic versions of its cardiac drug Entresto (sacubitril and valsartan), the company has filed…

Manufacturers of drugs, biologics and medical devices should be harnessing real-world data (RWD) at the postmarket stage, not just to support regulatory compliance but to generate ideas for innovative new…

Wayne Pines, senior director at APCO Worldwide, a former associate commissioner of the FDA, and a member of the FDAnews Editorial Board, provides his perspective on the likely direction of…

AMCO International Manufacturing & Design received an FDA Warning Letter because automated external defibrillator (AED) replacement batteries made by the firm have not received FDA approval. Source: Drug Industry Daily

The FDA issued six Warning Letters — to sellers including Amazon and Walmart — and created a drug safety page concerning sales of chemical skin peel products due to risk…

In this edition of Quick Notes, Abbott’s correction for Freestyle Libre 3 sensors, a new FDA webpage for LDTs, 510(k) clearance for Imperative Care catheters and eCential Robotics’ clearance for…

This Q and A is from the management report titled “Managing Data and Documentation for FDA Inspections and Remote Assessments,” based on a webinar from FDAnews, A WCG Company. The…

Kaleo received an “untitled letter” from the FDA Office of Prescription Drug Promotion (OPDP) because one of the company’s social media posts for Auvi-Q (epinephrine injection) does not include any…