Pharmaceutical Development Group (PDG) is a subsidiary of Biotech Research Group Corporation.
(Reuters) – “The U.S. Food and Drug Administration is aiming to approve drugs based on very early data if the drug shows a possible benefit in terms of survival, the head of the agency told lawmakers at a hearing on Thursday. Speaking before the House Committee on Energy and Commerce, FDA Commissioner Scott Gottlieb said…
“FDA draft guidance proposes collaborative approach to facilitate development of drugs for rare pediatric diseases… On December 6, 2017, the FDA issued draft guidance outlining a potential novel approach to develop new drug therapies for rare pediatric diseases. While Gaucher disease is the focus of the draft guidance, the purpose of the guidance is to facilitate drug development…
Because we spend such a significant amount of our time on the development of complex drug products (whether 505(j) or 505(b)(2) submissions), any workshop that includes discussion of new methods for characterizing and demonstrating equivalence tends to get our attention. CDER/OGD will be hosting Generic Orally Inhaled and Nasal Drug Products Workshop on January 9,…
Recently we reported EMA to Launch New Version of EudraVigilance. On November 22, 2017, EMA reported that “The European Medicines Agency (EMA) has launched today a new and improved version of EudraVigilance, the European information system of suspected adverse reactions to medicines that are authorised or being studied in clinical trials in the European Economic Area (EEA). The…
This is the tale of two stories: World Pharma News recently reported that “Results from two Phase 1 clinical trials show an experimental Zika vaccine developed by government scientists at the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health, is safe and induces an immune response in healthy…
Advancing Policies to Promote Safe, Effective MedTech Innovation Posted on December 11, 2017 in FDA Voice by Scott Gottlieb, M.D.: “Early in the coming year, FDA’s Center for Devices and Radiological Health (CDRH) intends to advance several important new regulatory policy initiatives to further modernize the medical devices program and continue to foster new medtech innovation…” Cited were…
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…
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…