Standards & Regulation - BioPharm International

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Standards & Regulation

Case Study Interprets Continuous Process Verification Guidance

August 11, 2014

The BioPhorum Operations Group has published a resource to help the biopharmaceutical industry deliver a consistent approach to continued process verification.

Changes and Challenges for Generic Drugs

August 1, 2014

FDA seeks high quality applications and products to facilitate approvals and reduce safety and supply problems.

FDA Publishes Guidance on ANDA Submissions

July 10, 2014

FDA clarifies GDUFA requirements in regards to abbreviated new drug applications and prior approval supplements.

EMA Recommends 39 Drugs in First Half of 2014

July 10, 2014

The European Medicine Agency details the agency?s recommendations for drug-marketing authorizations for the first half of 2014.

FDA Urged to Preserve Biosimilar Naming Conventions

July 2, 2014

Several groups, including pharmacies, call on FDA to preserve accepted International Nonproprietary Name conventions for biosimilars.

Supplier Audit Program Marks Progress

July 1, 2014

Supplier Audit Program Marks Progress

EMA Revises Guidance on Advanced Therapies

July 1, 2014

European Medicines Agency clarifies advanced-therapy medicinal products classification.

Industry Seeks Clearer Standards for Track and Trace

July 1, 2014

Stakeholders face challenges and benefits from a more secure pharmaceutical supply chain.

Challenges in Securing the Biopharma Supply Chain

July 1, 2014

Challenges in Securing the Biopharma Supply Chain

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