Pharmaceutical Development Group (PDG) is a subsidiary of Biotech Research Group Corporation.
November 26, 2017, the NY Times asks “He Raised Drug Prices at Eli Lilly. Can He Lower Them for the U.S.?… Alex M. Azar II, President Trump’s nominee to lead the Department of Health and Human Services, has expressed concern about the soaring cost of prescription drugs for many consumers. This week, Mr. Azar, a…
If you go to the EMA website and click “About us” you will read that “The European Medicines Agency (EMA) is a decentralised agency of the European Union (EU), located in London. It began operating in 1995. The Agency is responsible for the scientific evaluation, supervision and safety monitoring of medicines in the EU. EMA…
Sometimes we include a story because it’s simply fascinating: November 22 – “The U.S. Food and Drug Administration today approved the RxSight Inc. Light Adjustable Lens and Light Delivery Device, the first medical device system that can make small adjustments to the artificial lens’ power after cataract surgery so that the patient will have better…
In remarks made to the FTC on November 8, 2017, FDA Commissioner Scott Gottlieb, M.D. stated, in part: “So my message is this: end the shenanigans. Branded companies’ use of REMS – which FDA adopts as a way to ensure the safe use of certain drugs – is also sometimes being used as a way…
In October of this year, FDA issued guidance that for the first time formalized the Pre-ANDA Meeting for developers of complex generics. Entitled “Formal Meetings Between FDA and ANDA Applicants of Complex Products,” “This guidance describes an enhanced pathway for discussions between FDA and a prospective applicant preparing to submit or an applicant that has…
US News & World Report recently reported “Massachusetts Grabs Spotlight By Proposing New Twist On Medicaid Drug Coverage Other states are watching closely, officials say.” Following is an excerpt: “In the absence of new federal policies to tame break-the-bank drug prices, Massachusetts’ state Medicaid program hopes to road-test an idea both radical and market-driven. It wants the…