On January 18, 2017, the U.S. Department of Health and Human Services along with 15 other federal agencies issued the Final Rule to revise the Federal Policy for the Protection of Human Subjects, known as the “Common Rule.” This 1991 set of regulations created a …
FDA recently put forth its first interpretation of the Regenerative Advanced Therapy (“RAT”) designation program, which was established by section 3033 of the 21st Century Cures Act. Although it consists of just a few short paragraphs on FDA’s website (here), the guidance confirms that FDA …
The 21st Century Cures Act was signed into law on December 13, 2016. The Act addresses acceleration of medical product discovery, development, and delivery. Hyman, Phelps & McNamara, P.C. ("HP&M") will hold complimentary webinars on Thursday, January 12, 2017 from 12:00-1:30 PM (Eastern) and Wednesday, …
As we previously reported, the President signed into the law the 21st Century Cures Act (Act) on December 13, 2016 (find the full text here). This post is part two of a two-part post that summarizes the relevant provisions related to development of drugs and …
The 21st Century Cures Act (Act) was passed by the House on November 30, 2016 and the Senate on December 7, 2016. The President signed it into law on December 13, 2016. The Act contains three primary titles that address acceleration of medical product discovery, …
By James E. Valentine – In what can only be described as a success story, FDA’s Patient-Focused Drug Development (“PFDD”) initiative has opened the doors to hundreds of patients, caregivers, and other patient representatives to share their experiences with their diseases and conditions with FDA. This …
By James E. Valentine & David C. Clissold – Nearly two years after releasing its Notice of Proposed Rulemaking (“NPRM”), and with about 900 comments from the public to consider, the National Institutes of Health (“NIH”) has published its Final Rule on clinical trials registration and …
By Alexander J. Varond – One day before the program’s sunset, President Obama signed a bill to temporarily reauthorize the rare pediatric disease priority review voucher program for 3 months. The program has had significant interest from industry, and the program’s extension on September 30 was …
By Alexander J. Varond – Late last week, the Senate voted unanimously to extend the rare pediatric disease voucher program until December 31, 2016. In doing so, it also voted to amend the definition of “rare pediatric disease” set forth in Section 529 of the Federal …
By Alexander J. Varond – FDA’s rare pediatric disease priority review voucher program is set to expire on October 1. If this happens, FDA will no longer award pediatric vouchers to otherwise eligible sponsors. Expiration of the pediatric voucher program would mean the end (at least …
By Jay W. Cormier – As readers of this blog may recall, FDA observed remarkable conditions at two facilities on the NIH campus in Bethesda, MD (see our post here). Then, earlier this year, NIH stated again that it was closing its drug manufacturing facilities (see …
A breakthrough paper by Hyman, Phelps & McNamara, P.C’s Frank Sasinowski and Alexander Varond concerning FDA’s Subpart H approvals has just published in the Food and Drug Law Journal. Titled “FDA’s Flexibility in Subpart H Approvals: Assessing Quantum of Effectiveness Evidence,” the paper examines the …
By Karla L. Palmer – FDA posted a “Notice” on July 12, 2016, advising compounding pharmacies regulated under Section 503A that, effective August 1, 2016, FDA is changing inspection procedures for Section 503A pharmacies (see Notice here). FDA announced that it now will make a “preliminary assessment” whether compounders …
By James E. Valentine & Alexander J. Varond – FDA recently issued draft guidance, entitled “Special Protocol Assessment,” which, when finalized, will replace FDA’s 2002 final guidance by the same title. At 23-pages long, the draft guidance is much more thorough than its predecessor (only 11 …
By Jay W. Cormier – The National Institutes of Health (NIH) recently announced that it would be suspending drug manufacturing at two of its facilities after preliminary findings by two outside consulting groups found that certain sterile products were not manufactured in compliance with GMP quality …
