FDA Related News

Human Drugs

Guardian Pharmacy Services Consent Decree

A Texas federal judge approves a consent decree sought by FDA against Guardian Pharmacy Services, a drug compounder.

Federal Register

Docket Corrected on Data Integrity Guidance

Federal Register notice: FDA corrects a 12/13/2018 notice entitled Data Integrity and Compliance With Drug CGMP: Questions and Answers; Guidance for I...

Federal Register

Info Collection Extension for HDE Submissions

Federal Register notice: FDA seeks comments on an information collection extension for Information To Accompany Humanitarian Device Exemption Applicat...

Federal Register

Info Collection Extension for Review Program Evaluation

Federal Register notice: FDA seeks comments on an information collection extension for Evaluation of the Program for Enhanced Review Transparency and ...

Human Drugs

CGMP Violations at Hospira Healthcare India

FDA warns Hospira Healthcare India about CGMP violations in its production of finished pharmaceuticals.

Human Drugs

NCI Head Sharpless Appointed FDA Acting Commissioner

HHS secretary Alex M. Azar III appoints National Cancer Institute director Norman E. Sharpless to serve as acting FDA commissioner after Scott Gottlie...

Medical Devices

Software Precertification Program Comments

Two stakeholders make suggestions for revising the FDA software precertification working model.

Covidien Settling False Claims Act Case for $17 Million

The Justice Department says Covidien is paying more than $17 million in settle False Claims Act whistleblower allegations that it illegally provided s...

FDA General

Latest FDA Warning Letters

FDA releases its latest batch of Warning Letters that include Anicare Pharmaceutical, Jubilant Life Sciences, Laboratorios Quantium and Pfizer (Hospir...

Human Drugs

FDA OKs Alkem Labs Generic Diovan to Help Shortages

FDA approves an Alkem Laboratories ANDA for a new generic of Diovan (valsartan), an angiotensin II receptor blocker that treats high blood pressure an...