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Guidance on Box Warning Sections of Drug, Biologic Labeling

[ Price : $8.95]

Federal Register Notice: FDA releases a guidance on drafting warnings and precautions, contraindications, and box warning sections...

Workshop on Infectious Diseases Relevant to Blood/Blood Products

[ Price : $8.95]

Federal Register Notice: FDA schedules a public workshop 11/29 on data and data needs to advance risk assessment for emerging infe...

CBER Revises Biological Product Deviation Codes

[ Price : $8.95]

CBER revises its listing of Biological Product Deviation Codes for manufacturers filing a reportable event to FDA.

Info on Appeals to CVM Sent to OMB

[ Price : $8.95]

Federal Register Notice: FDA submits a proposed collection of information on appeals of science-based decisions at the Center for ...

Latest FDA Warning Letters

[ Price : $8.95]

In its latest batch of Warning Letters FDA cites Botanic Oil Innovations and X-Ray Support.

FDA Approves an Edgemont NDA for Fluoxetine 60mg

[ Price : $8.95]

FDA approves an Edgemont Pharmaceutical NDA for fluoxetine tablets 60 mg, the active ingredient in Eli Lilly's Prozac.

Quality System Problems at X-Ray Support

[ Price : $8.95]

FDAs Seattle District Office warns X-Ray Support, Inc. about Quality System and registration violations in its manufacturing of de...

Labeling Content and Format Guidance

[ Price : $8.95]

FDA issues a guidance on content and format of specific labeling sections for human Rx drug products and biologicals.

Physical-Chemical Identifier Guidance

[ Price : $8.95]

FDA issues a guidance to help drug manufacturers incorporate physical-chemical identifiers into solid oral dosage forms.

EC Proposes Revised Rx Drug Information Requirements

[ Price : $8.95]

The European Commission proposes revising requirements on information that drug companies can give to the public on Rx medicines.