By James E. Valentine* & Anne Marie Murphy – The National Institutes of Health (“NIH”) just extended the comment period for its Notice of Proposed Rulemaking on clinical trial registration and results submission (“NPRM”) until March 23, 2015. As we previously reported, the NPRM proposes to …
By James E. Valentine* & Jim C. Shehan – The 21st Century Cures Act’s focus on patients is inescapable. Title I of this nearly 400 page bill is entitled, “Putting Patients First By Incorporating Their Perspectives Into The Regulatory Process and Addressing Unmet Needs.” When we reported …
By James E. Valentine* & Anne Marie Murphy – The first month of 2015 has seen two policy proposals that would expand clinical trials data sharing. On January 14, the Institute of Medicine (“IOM”) released its report on “Sharing Clinical Trial Data: Maximizing Benefits, Minimizing Risks,” …
By Kurt R. Karst – For months we have been waiting with bated breath for the promised January 2015 release of a discussion draft of legislation to implement the 21st Century Cures Initiative, which was launched in April 2014 by now-Chairman of the House Energy and …
By James E. Valentine* & Anne Marie Murphy – As we previously reported, last month the National Institutes of Health (“NIH”) published a Notice of Proposed Rulemaking on clinical trials registration and results submission (“NPRM”), and is requesting public comment by February 19, 2015. The NPRM generally …
By James C. Shehan – Over the past year, the plight of seriously ill patients seeking access to unapproved drugs has led five states to pass laws that permit manufacturers to provide patients in those states with investigational drugs on an emergency basis without going through …
By James E. Valentine* & Anne Marie Murphy – On November 19, 2014, the National Institutes of Health (“NIH”) announced the much anticipated Notice of Proposed Rulemaking on clinical trials registration and results submission (“NPRM”). While the Food and Drug Administration Amendments Act (“FDAAA”) Section 801 …
By Alexander J. Varond & Anne K. Walsh – On November 17, 2014, FDA announced the availability of its draft guidance entitled, “Rare Pediatric Disease Priority Review Vouchers.” The draft guidance “is intended to assist developers of rare pediatric disease products in assessing whether their product may be …
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 …
