Standards & Regulation - BioPharm International

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Standards & Regulation

FDA Releases Guidance on Vial Fill Size

March 13, 2014

FDA clarifies recommendations for injectable drug products packaged in vials and ampules.

FDA Details National Vaccine Plan

March 11, 2014

HHS plan makes progress in ensuring availability of safe vaccines.

FDA and EMA Extend QbD Parallel-Assessment Pilot Program

March 6, 2014

Agencies extend successful pilot program to further harmonization of QbD topics.

FDA Releases Guidance on CMC Postapproval Changes

March 4, 2014

New guidance from FDA asks for documentation of CMC postapproval manufacturing changes.

Manufacturers Struggle with Breakthrough Drug Development

March 1, 2014

Accelerated testing and production create challenges in documenting product quality.

European Union Packaging Safety Features Come into Effect

March 1, 2014

Manufacturers are taking measures to comply with new package safety rules.

Control Strategies for Synthetic Therapeutic Peptide APIs— Part I: Analytical Consideration

March 1, 2014

USP evaluates quality attributes for synthetic peptides.

Regulators Get Tough on Corruption in China

March 1, 2014

China's regulatory and compliance environment is set to change as the government declares a crackdown on bribery scandals.

FDA Issues Draft Guidance on NCE Exclusivity Determinations

February 25, 2014

FDA revises interpretation of the five-year NCE exclusivity provisions for certain fixed-combination drug products.

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