Standards & Regulation - BioPharm International

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Standards & Regulation

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.

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 Publishes Guidance on ANDA Submissions

July 10, 2014

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

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.

Challenges in Securing the Biopharma Supply Chain

July 1, 2014

Challenges in Securing the Biopharma Supply Chain

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.

FDA Outlines Guidance and Rules for Compounding Drug Products

July 1, 2014

FDA releases guidance documents and rules on requirements for compounding human drug products.

Supplier Audit Program Marks Progress

July 1, 2014

Supplier Audit Program Marks Progress

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