On January 16, 2008, FDA issued a proposed rule that would “reaffirm [the Agency’s] longstanding position that” labeling changes for approved drugs, biologics, and medical devices may only be made to show newly acquired information or to “add or strengthen a contraindication, warning, precaution, or …
On February 8, 2008, Hyman, Phelps & McNamara, P.C. (“HPM”) is sponsoring a Medical Device Seminar in Newport Beach, California. The topic of this seminar will be “Striving for Regulatory Success in a Changing Environment.” Scheduled speakers for the seminar are Jeff Gibbs, Brian Donato, …
Title VIII of the recently-enacted FDA Amendments Act (“FDAAA”) requires the responsible party of an applicable clinical trial (for both drugs and devices) to certify that the new requirements of Public Health Service Act (“PHS Act”) § 402(j) have been met. Under PHS Act § …
In the preemption world, “fraud on the FDA” cases are fairly common. As one court recently used the term, fraud on the FDA means a drug or a medical device company is liable to someone who was injured by their product if that product was …
Late last week, FDA announced several steps intended to strengthen the advisory committee process. The announced improvements are part of a broader FDA effort to address recommendations made by the Institute of Medicine in its September 2006 report, titled "The Future of Drug Safety: Promoting …
Title VI of the recently-enacted FDA Amendments Act (“FDAAA”) amended the FDC Act to establish a non-profit corporation whose purpose is to advance FDA’s Critical Path Initiative to “modernize medical, veterinary, food, food ingredient, and cosmetic product development, accelerate innovation, and enhance product safety.” (The …
The Department of Health and Human Services’ (“DHHS”) Office of Inspector General (“OIG”) recently announced its Fiscal Year 2008 Work Plan. The OIG Work Plan, issued annually, sets forth various projects to be addressed during the coming fiscal year by the Office of Counsel to …
Earlier today, Hyman, Phelps & McNamara, P.C. issued its detailed summary and analysis of the recently-enacted FDA Amendments Act (“FDAAA”). A copy of the summary and analysis is available here. FDAAA reauthorizes several user fee and pediatric-related laws, and includes a host of new provisions, …
Late today, the U.S. Senate passed FDA reform legislation by unanimous consent. The Senate vote follows the House’s action yesterday when it passed H.R. 3580, the FDA Amendments Act of 2007. Earlier in the day there was some concern that the Senate vote on the …
House and Senate staff have reportedly reached an agreement on omnibus FDA reform legislation that would, among several other things, reauthorize the Prescription Drug User Fee Act (“PDUFA”) through fiscal year 2012. Earlier today, a “staff agreement” (427 pages) and summary of the legislation was …
FDA announced on September 14, 2007 the release of a final guidance document pertaining to analyte specific reagents (“ASRs”), titled “Guidance for Industry and FDA Staff – Commercially Distributed Analyte Specific Reagents (ASRs): Frequently Asked Questions” (“the ASR Guidance”). A draft version of this guidance …
Hyman, Phelps & McNamara, P.C.’s Brian J. Donato cautioned companies about the dangers of “residual risk” while speaking at a recent conference on risk management sponsored by AdvaMed. Medical Device & Diagnostic Industry reported on the speech in an August 2007 article. Residual risk, which …
FDA has released a new draft guidance for In Vitro Diagnostic Multivariate Index Assays (“IVDMIAs”). The first version, which was released on September 7, 2006, attracted many critical comments. The new draft seeks to address some (but not all) of those concerns. Creating a new …
On June 25, 2007, the Supreme Court agreed to hear Riegel v. Medtronic, Inc., which concerns whether the FDC Act preempts state tort claims regarding medical devices that entered the market pursuant to the Premarket Approval (“PMA”) process. In 1996, the Supreme Court held in …
The FDA announced it is postponing the annual registration of medical device establishments for 2008. The agency said this is a temporary action and it expects to resume annual registrations in October or November 2007. Establishments that are already registered for 2007 are valid until …
