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Human Drugs

PMR/PMC Annual Statistical Report

FDA says most postmarketing reports and commitments are generally progessing on schedule, according to the FY 2021 annual report.

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Consider Mfg. Issues in Preparedness Planning: GAO

The Government Accountability Office says a new HHS program to produce medical countermeasures such as drugs and vaccines should assess challenges and...

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Marketing

GoodRx Paying $1.5 Million for Consumer Data Breach

The Federal Trade Commission says GoodRx will pay a $1.5 million civil penalty for failing to tell consumers and others about the unauthorized disclos...

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Ways to Mitigate Park Doctrine Risks: Attorney

Attorney Amanda Johnston explains five steps FDA-regulated company executives can take to mitigate the risk of Park Doctrine violations.

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Medical Devices

Expanded Indication for Abbott Heart Catheter

FDA approves an expanded ventricular tachycardia indication for Abbotts FlexAbility catheter.

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Federal Register

Fraudulent Contract Research Org. Leads to Debarment

Federal Register notice: FDA issues debarment order against Sami Anwar that bars him from providing services related to an approved or pending drug pr...

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Glucosamine Case Can Inform Drug, Device Cases: Attorney

Attorney Stephen McConnell explains how a recent court decision in a glucosamine supplement preemption case can be instructive to drug and medical dev...

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Human Drugs

M13A Bioequivalence Consensus Guideline

FDA publishes the International Council on Harmonization M13A guidance on bioequivalence for immediate-release solid oral dosage forms.

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Human Drugs

Positive Covid Test Requirement Lifted on 2 Therapeutics

FDA says two Covid-19 therapeutics can now be prescribed without having a positive test result showing Covid-19 infection when a physician suspects su...

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Federal Register

FDA Panel to Review 2 RSV Vaccines

Federal Register notice: FDA announces a 2/28 to 3/1 Vaccines and Related Biological Products Advisory Committee meeting to discuss two BLAs for respi...