FDA In Brief: FDA provides guidance on improving the agency’s interactions with product developers to make the drug development process more informed and efficient

Manual resuscitator recalled due to incorrect B/V filter assembly that could delay therapy. May cause hypoxia, hypercapnia, or death if used.

FDA Rationale for Breakpoints Recognition Decision: Azithromycin and Neisseria gonorrhoeae

This webinar will provide an in-depth look at the draft ICH M13B guideline titled “Bioequivalence for Immediate-Release Solid Oral Dosage Forms: Additional Strengths Biowaiver” that was endorsed by the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) Assembly in March 2025.

Task Description Request Please post to the OII FOIA Electronic Reading Room
Record Date 04/25/2025
Short Title (70 char) Wells Pharmacy Inc. Dyersburg, TN. 483 issued 04/25/2025
FEI Number 3011761321
Firm Name Wells Pharmacy Inc.
Record Type 483
State TN
Establishment Type Outsourcing Facility

FDA believes it is critically important to ensure that the promotional messages companies use to introduce new drugs are accurate and balanced as these messages form the public’s first impression of new drugs.

The FDA has received reports of immune effector cell-associated enterocolitis (IEC-EC) in patients who received treatment with CARVYKTI.