Regulatory Focus, Zachary Brennan, December 6, 2017: “The US Food and Drug Administration’s (FDA) Toxicology Working Group this week laid out a six-part roadmap to help the agency better evaluate new methodologies and technologies for their potential to expand FDA’s toxicology predictive capabilities and to potentially reduce the use of animal testing… The six-part framework…
DetailsNovember 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…
DetailsIf 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…
DetailsSometimes 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…
DetailsIn 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…
DetailsIn 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…
DetailsUS 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…
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On November 22, 2017, EMA launches a “new and improved” version of EudraVigilance (analogous to FDA Medwatch program). The result will be a total transition in the way that Individual case safety reports (ICSRs) are tracked and reported throughout Europe. ICSRs will be reported to the EudraVigilance database in the E2B(R3) format, replacing the E2B(R2)…
DetailsOn November 22, 2017, EMA launches a “new and improved” version of EudraVigilance (analogous to FDA Medwatch program). The result will be a total transition in the way that Individual case safety reports (ICSRs) are tracked and reported throughout Europe. ICSRs will be reported to the EudraVigilance database in the E2B(R3) format, replacing the E2B(R2) format.…
DetailsThe AAPS 2017 Annual Meeting & Exposition will be held in San Diego November 12-15. The exhibit hall will be open as follows: Monday November 13, 2017 10:30 AM – 5:00 PM Tuesday November 14, 2017 8:30 AM – 5:00 PM Wednesday November 15, 2017 8:30 AM – 1:30 PM CROs: come see us about…
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