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Human Drugs

CGMP Consultant Recommended for Cellex-C

FDA warns Canadas Cellex-C drug manufacturing firm about significant CGMP violations.

Human Drugs

Multiple Violations Found at Philippines Skin Sciences

FDA warns the Philippines Skin Sciences Laboratory about CGMP violations in its production of misbranded unapproved new drugs.

Human Drugs

10 Inspection Observations in Biocon 483

FDA releases the FDA-483 issued following an inspection at Indias Biocon sterile drug manufacturer.

Human Drugs

Meeting Next Month on Assessing Benefits/Risks

FDA announces a 9/18 public meeting to discuss topics related to the structured assessment of benefits and risks in drug regulatory decision-making.

Biologics

FDA Cautions Doctor Over 3-Parent Baby

FDA tells a U.S. fertility doctor he cant market his spindle nuclear transfer technique to help some women conceive.

Human Drugs

Draft Unit-Dose Expiration Dating Guidance

FDA issues a draft guidance explaining its enforcement discretion for expiration dating of repackaged unit-dose solid oral dosage form drugs.

Federal Register

Comments Sought on Biologic Manufacturing Arrangements

Federal Register notice: FDA seeks comments on an information collection extension for its Guidance for Industry: Cooperative Manufacturing Arrangemen...

Federal Register

Comments Sought on Drug Ad Information Requirements

Federal Register notice: FDA seeks comments on an information collection for Prescription Drug Advertisements.

Federal Register

48 ANDA Bioequivalence Guidances Published

Federal Register notice: FDA announces the availability of 48 final product-specific guidances that recommend the design of bioequivalence studies to ...

Federal Register

Oncologic Drugs Panel to Review Sutent sNDA

Federal Register notice: FDA announces a 9/19 Oncologic Drugs Advisory Committee meeting to review a C.P. Pharmaceuticals supplemental NDA for Sutent.