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March 24, 2015
The agency provides guidance on determining the need for environmental assessments for gene therapies, vectored vaccines, and viral and microbial products.
March 23, 2015
Guidance provides labeling standards and an implementation guide for electronic submission of lot distribution reports.
March 17, 2015
NSF's consensus-based standard incorporates multiple regulatory and industry requirements into a single rigorous standard for the manufacturing and distribution of pharmaceutical excipients.
March 13, 2015
McNeil-PPC pleads guilty in connection with adulterated infants' and children's over-the-counter liquid medications.
March 02, 2015
A new technical report guides bio/pharma companies in establishing a risk-based approach for prevention and management of drug shortages.
Assessing risk factors is key to implementing the new ICH Q3D guidelines for elemental impurities.
Cleanability is crucial when choosing components for GMP manufacturing areas.
February 24, 2015
The company voluntarily recalls product due to FDA observations of potential sterility problems.
February 23, 2015
The agency cites Apotex’s Bangalore facility with quality system failures.
February 17, 2015
The agency releases five draft guidance documents related to drug compounding and repackaging.