Pharmaceutical Development Group (PDG) is a subsidiary of Biotech Research Group Corporation.
NADA Q reported on December 19, 2016 that “Mylan N.V. announced the launch of the first generic version of its life-saving allergy treatment, EpiPen® auto-injector, at more than 50% discount on the branded product’s price. The generic EpiPen® will have a list price of $300 for a pack of two and will reach pharmacies beginning…
Last month, we reported that New Guidance on Medical Device Reporting Supersedes Guidance in Use Since 1997. This guidance document is intended to assist medical device manufacturers meet applicable reporting and recordkeeping requirements for certain device-related adverse events and malfunctions. There have been numerous changes to the medical device reporting requirements since the FD&C Act…
According to the Background, “This guidance outlines the recommended format and content for a sponsor to submit physiologically based pharmacokinetic (PBPK) analyses to the FDA to support applications including investigational new drug (INDs) applications, new drug applications (NDAs), biologics license applications (BLAs), or abbreviated new drug applications (ANDAs). To enable efficient and consistent review, the…
According to FDA Commissioner Robert M. Califf, M.D. and Nina L. Hunter, Ph.D., FDA’s Associate Director for Science Policy in the Office of Medical Products and Tobacco, “About a year ago, we shared with you our Combination Product Review, Intercenter Consult Process Study Report, which was developed by FDA’s Office of Planning. The report’s findings were…
The Washington Post recently reported that “The bill provides for $4.8 billion in new funding for the National Institutes of Health; of that, $1.8 billion is reserved for the “cancer moonshot” launched by Vice President Biden to accelerate research in that field. Another $1.6 billion is earmarked for brain diseases including Alzheimer’s. Also included are…
FiercePharma recently reported “Trump wants to battle high drug prices? Let’s work together, hike-fighting senator says.” In the story, Sen. Amy Klobuchar (D-Minnesota), has a message for President-elect Donald Trump: “Let’s bring drug prices down together… In a new op-ed for USA Today, Sen. Klobuchar outlined several tactics that, if implemented, would reduce prices in the U.S., she…