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Current Issue
Maintaining Cell Line Integrity
The quality of the cell lines used to manufacture biopharmaceuticals are crucial for the production of high-quality, stable biopharmaceuticals.
A New Paradigm in Drug Development
The changing regulatory and manufacturing environment is ushering in a new approach to drug development.
Submitting Extractables and Leachables Data to Regulators
The type of product, the packaging materials being used, and the process and materials used to manufacture the product will determine when E&L data should be submitted to regulators, says Susan J. Schniepp, executive vice-president, Post-approval Pharmaceuticals and distinguished fellow at Regulatory Compliance Associates.
Outsourcing
FDA Approves Drug Product Manufacturing for Samsung BioLogics
Drug product approval from FDA follows previous approvals from European and Japanese authorities.
Joseph Polli Named AAPS President-Elect
Pharmaceutical scientist association announces upcoming term’s board of directors.
Biopharma Seeks Balance
Biopharma companies can balance competing demands from patients, investors, and regulators by keeping a focus on science.
Fifteen Years of Progress: Biopharmaceutical Industry Survey Results
This article highlights 15 years of changes in biopharmaceutical manufacturing.
Standards/Regulations
FDA Commissioner Gottlieb Releases Statement on Advancement of Gene Therapies
The agency is releasing six new draft guidances to provide a regulatory framework for handling gene therapies.
CGMP Violations Found at India Facility
FDA sent a warning letter to Goran Pharma Private Limited citing inadequate quality control violations.
Trump Drug Pricing Plan Outlines Rule Changes Pharma Can Live With
President Donald Trump announced his strategy for making prescription medicines more affordable and accessible in the United States.
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