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August 24, 2015
Andrew Bulpin, executive vice president of EMD Millipore’s Process Solutions Business, speaks to Pharmaceutical Technology about the trends shaping the biopharmaceutical manufacturing industry.
The Reagan-Udall Foundation for the FDA (RUF) is overcoming initial roadblocks and gaining support from a range of public and private organizations.
Manufacturers seek gradual rollout of more targeted FDA quality metrics program.
August 18, 2015
Regulatory officials and industry scientists participated in a CMC Strategy Forum sponsored by CASSS in July 2015.
July 31, 2015
Competitive pressures are driving more companies to repurpose APIs that had originally been developed for other indications. The industry has only "scratched the surface" of what might be possible, says consultant Hermann Mucke
July 29, 2015
The broader aim of FDA's metrics initiative is to encourage quality manufacturing operations that will help avoid drug shortages.
July 24, 2015
Manufacturers are producing new drugs and vaccines and clinical supplies faster and more efficiently through the development of standards and common practices for single-use technology systems.
As more patents make their way through IPRs, the balance of how the pharmaceutical industry selects between IPRs and district court litigation will likely evolve.
July 17, 2015
A year-long process reauthorizing the Prescription Drug User Fee Act was launched July 15, 2015 with a public meeting, setting the stage for discussions with industry and FDA.
July 14, 2015
Important research is under way that will help us understand the extent of the presence of substandard, adulterated and counterfeit drugs around the world, and, thus, strengthen enforcement efforts and public outreach programs. Future studies will focus on the API and overall chemical content