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Animal Drugs

FDA Animal Antibiotic Concept Paper Substantially Flawed: Pew

The Pew Charitable Trusts says an FDA concept paper on the duration of use of medically important antibiotic drugs used in or on animal feed needs sig...

Human Drugs

Keep Drug Companies Outside Clinical Trial Networks: Woodcock

FDA acting commissioner Janet Woodcock calls for greater independence from drug companies in the nations clinical trial processes and procedures.

Federal Register

Vaccines Panel to Discuss Pediatric Covid Vaccines

Federal Register notice: FDA announces a 6/10 Vaccines and Related Biological Products Advisory Committee meeting to discuss Covid19 pediatric vaccine...

Federal Register

Panel to Review FibroGen Anemia Drug

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

Federal Register

Device Code Labeling Final Guidance

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

Federal Register

Guide on Bioequivalence for Soluble Powder Products

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

Medical Devices

Medical Action Recalls Convenience Kits

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

Federal Register

Draft Guide on Covariates in Clinical Trials

Federal Register notice: FDA releases a draft guidance on adjusting for covariates in drug/biologic clinical trials.

Human Drugs

Bispecific Antibody Development Guidance

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

Human Drugs

CDER Wants Firms to Achieve Quality Management Maturity

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