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10 Observations in Hospira FDA-483

[ Price : $8.95]

FDA releases an FDA-483 with 10 observations from an inspection at a Hospira sterile drug manufacturing facility.

Guide on Bioequivalence for Soluble Powder Products

[ Price : $8.95]

Federal Register notice: FDA makes available a final guidance on demonstrating bioequivalence for soluble powder drug products.

Medical Action Recalls Convenience Kits

[ Price : $8.95]

Medical Action Industries recalls its Medical Convenience Kits that include the BD/Carefusion Chloraprep 3mL applicator, which was...

Draft Guide on Covariates in Clinical Trials

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Federal Register notice: FDA releases a draft guidance on adjusting for covariates in drug/biologic clinical trials.

Bispecific Antibody Development Guidance

[ Price : $8.95]

FDA issues a final guidance on regulatory, quality, nonclinical, and clinical considerations for bispecific antibody development p...

CDER Wants Firms to Achieve Quality Management Maturity

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CDER director Patrizia Cavazzoni says the Center will apply an intense focus to encourage the pharmaceutical industry to achieve q...

Vaccines Panel to Discuss Pediatric Covid Vaccines

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Federal Register notice: FDA announces a 6/10 Vaccines and Related Biological Products Advisory Committee meeting to discuss Covid...

Panel to Review FibroGen Anemia Drug

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Federal Register notice: FDA announces a 7/15 Cardiovascular and Renal Drugs Advisory Committee meeting to review FibroGen anemia ...

Device Code Labeling Final Guidance

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Federal Register notice: FDA posts a final guidance on an extended enforcement policy regarding use of national health related ite...

Peripheral Vascular Atherectomy Devices

[ Price : $8.95]

Federal Register notice: FDA makes available a final guidance on premarket submissions for peripheral vascular atherectomy devices...