By James E. Valentine* & James C. Shehan – On November 4, 2014, FDA’s Office of Health and Constituent Affairs and an Agency-wide working group posted a notice requesting comments generally on all its various patient engagement activities and specifically on FDASIA Section 1137— the provision on …
By Etan J. Yeshua – Drug developers targeting acute migraines may now have a new path to approval. In a draft guidance document issued on Tuesday by the Division of Neurology Products ("DNP"), FDA offers a novel primary endpoint that has not been used before to …
By Kurt R. Karst – As most folks know by now, earlier this month the President’s Council of Advisors on Science and Technology (“PCAST”) released a report to the President titled “Combating Antibiotic Resistant Bacteria.” The report is part of a broader initiative announced by The …
By James E. Valentine* – Whether you call it “patient advocacy,” “patient engagement,” or maybe something a little fancier, in recent years incorporating the patient perspective has become a hot topic issue for FDA and drug developers alike. As FDA stated in announcing its Patient Focused …
By James E. Valentine* – On September 10, 2014, the FDA hosted its 3rd Annual Patient Network Meeting, “Under the Microscope: Pediatric Drug Development,” to explore challenges related to pediatric drug development. The Patient Network is a program run out of FDA’s Office of Health and …
By Jennifer D. Newberger — We previously posted about CDRH’s guidance on the appeals process contained in the Food and Drug Administration Safety and Innovation Act (FDASIA), and its issuance of a draft Q&A discussing section 517A. Section 517A imposed timeframes for appeal decisions that were …
By Kurt R. Karst – “Driveway moments” – most of us have had them. It’s that moment when we feel compelled to stay in the car and finish listening to something on the radio. This blogger recently had such a moment commuting home from work on …
By Alexander J. Varond — FDA recently released its report entitled “Complex Issues in Developing Drugs and Biological Products for Rare Diseases and Accelerating the Development of Therapies for Pediatric Rare Diseases Including Strategic Plan: Accelerating the Development of Therapies for Pediatric Rare Diseases.” The report fulfills the …
By James E. Valentine* & Sara A. Khan** – On July 11, 2014, the House Energy and Commerce’s Subcommittee on Health held its fourth hearing, as part of its 21st Century Cures Initiative, to seek input regarding the incorporation of patient perspectives in drug development and …
By James C. Shehan & Karla L. Palmer – In a curious posting on Friday, June 20, 2014, FDA with little fanfare set forth its latest position on medical marijuana. Amounting to little more than a statement of general support of scientific research on medical marijuana …
By Kurt R. Karst – The so-called “drug lag” – i.e., the difference (or perceived difference some might say) in drug availability between the United States and other countries – was one of myriad reasons some folks back in the early 1990s thought it was necessary …
By Kurt R. Karst – Interest in and efforts to address shortfalls in the inclusion of women in clinical trials and clinical research, and differences in the sexes in drug development are not new. There’s the National Institutes of Health (“NIH”) Revitalization Act of 1993, which …
GTCbio recently announced that it will be holding the 4th Annual CNS Diseases World Summit from September 18-19, 2014 in San Francisco, California. The summit consists of two individual conferences that will run in parallel: (1) the 7th CNS Partnering & Deal-Making conference; and (2) …
By James E. Valentine – On June 11, 2014, a panel before the House Energy and Commerce Committee’s Subcommittee on Health hosted its second hearing on the 21st Century Cures Initiative. The Subcommittee sought input on whether current economic and regulatory incentives are sufficient to encourage …
By Alexander J. Varond – On May 29, FDA issued its final guidance on “Expedited Programs for Serious Conditions – Drugs and Biologics.” We blogged previously on the draft guidance and each of FDA’s four expedited programs (fast track designation, accelerated approval, priority review, and breakthrough …
