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Biologics

Committee Documents Emergent Manufacturing Failures

A House committee staff report blasts Emergent Biosolutions for hiding its Covid-19 vaccine manufacturing problems from FDA and HHS.

Human Drugs

Lillys Olumiant Approved for Covid-19

FDA approves a new indication for Eli Lillys Olumiant (baricitinib) for treating Covid-19 in hospitalized adults requiring supplemental oxygen, non-in...

Biologics

CBER Ups Likely 2022 Guidances

CBER increases from 13 to 17 the number of guidances it expects to develop in 2022.

Medical Devices

FDA Needs More Digital Power: Patel

Former FDA Digital Health Center of Excellence director Bakul Patel says the agency needs additional congressional authorities to fully implement its ...

Federal Register

Glucotrol Not Withdrawn Due to Safety/Efficacy: FDA

Federal Register notice: FDA determines that Pfizers Glucotrol (glipizide) tablets, 2.5 mg, were not withdrawn from sale due to safety or effectivenes...

Federal Register

Drug Quality Assessments Guidance

Federal Register notice: FDA makes available a draft guidance entitled Benefit-risk Considerations for Product Quality Assessments.

Human Drugs

Eisai BLA for Alzheimers Therapy

Eisai files a rolling BLA submission under the accelerated approval pathway for its investigational anti-amyloid beta protofibril antibody lecanemab (...

Federal Register

FDA Revokes EUAs on 2 Covid Tests

FDA revokes a Bio-Rad Laboratories Emergency Use Authorization (EUA) and a Bio- Applied DNA Sciences EUA for their no-longer-distributed Covid-19 test...

Human Drugs

Guidance on Considerations for Drug Quality Assessments

FDA posts a draft guidance entitled Benefit-Risk Considerations for Product Quality Assessments, which describes the agencys benefit-risk principles u...

Medical Devices

Draft Guide on Cybersecurity for Legacy Devices

The International Medical Device Regulators Forum (IMDRF), of which FDA is a member, seeks comments on a proposed guidance entitled Principles and Pra...