By Kurt R. Karst – Two new reports were published this week analyzing FDA’s performance under the Prescription Drug User Fee Act (“PDUFA”). The reports – one from the California Health Institute (“CHI”) and The Boston Consulting Group (“BCG’), and another from the Tufts Center for …
By Kurt R. Karst – Representative Tom Reed (R-NY) recently introduced legislation (H.R. 5283) that is intended to clarify that the PHS Act’s clinical trial registry data bank reporting requirements apply to clinical trials regardless of a trial’s outcomes. The bill would also amend the PHS …
By Kurt R. Karst – A report released earlier this week by the Government Accountability Office (“GAO”) says that FDA has met most of the Agency’s PDUFA performance goals for priority and standard original NDA and BLA submissions and for priority and standard original efficacy supplements …
By Nisha P. Shah – FDA issued a final rule that amends the regulations to expand the scope of disqualification of clinical investigators. 77 Fed. Reg. 25353 (Apr. 30, 2012). We previously reported on the proposed rule issued in April 2011, and there are no substantive …
By John R. Fleder & Jennifer M.Thomas— As previously reported here, on April 13, 2012 ViroPharma Incorporated (“ViroPharma” sued FDA to challenge the agency’s April 9, 2012 approval of three Abbreviated New Drug Applications (“ANDAs”) for generic versions of the company’s antibiotic drug Vancocin® (vancomycin hydrochloride). …
By Kurt R. Karst & David B. Clissold – Three House lawmakers (Reps. Henry Waxman(D-CA), Ed Markey (D-MA), and Diana DeGette (D-CO)) sent letters (here and here) to FDA Commissioner Dr. Margaret Hamburg and NIH Director Francis Collins earlier this week expressing their concern over a …
By Nisha P. Shah – On February 9, 2012, FDA released a new guidance document called, “Guidance For Sponsors, Investigators, and Institutional Review Boards – Questions and Answers on Informed Consent Elements, 21 CFR § 50.25(c).” The guidance is intended to help small businesses understand the …
By Kurt R. Karst – A new report released by the Government Accountability Office (“GAO”), titled “Antibiotics: FDA Needs to Do More to Ensure That Drug Labels Contain Up-to-Date Information,” says that since the September 27, 2007 enactment of the FDA Amendments Act (“FDAAA”) FDA has …
By Kurt R. Karst – Representatives Cliff Stearns (R-FL) and Ed Towns (D-NY) recently introduced H.R. 3737, the Unlocking Lifesaving Treatments for Rare-Diseases Act (“ULTRA”). The bill would amend the FDC Act to “improve access to the existing accelerated approval pathway for patients with life threatening …
By Kurt R. Karst – Just one day after FDA announced a December 16th public meeting and comment period to discuss the Agency’s proposed recommendations for a user fee program for biosimilar biological products for Fiscal Years (“FYs”) 2013 through 2017 (see our post here), the …
By Kurt R. Karst – On December 7, 2011, FDA will publish a Federal Register notice – a prepublication version of which is available here – announcing a December 16th public meeting and comment period (Docket No. FDA-2011-N-0326) to discuss the Agency’s proposed recommendations for a …
The International Conference on Drug Development (“ICD2”), formerly known as the International Industrial Pharmacy Conference, continues its annual tradition of offering an informal forum for the exchange of ideas concerning the drug discovery and development process. The 2012 conference, which is presented by The University …
By Kurt R. Karst – Almost a year after having notified Genentech of a proposal to withdraw the approval of Avastin® (bevacizumab) for use with paclitaxel for the treatment of patients who have not received chemotherapy for metastatic HER2-negative breast cancer, and almost five months after …
By Jennifer M. Thomas – President Obama issued an Executive Order earlier this week to address the growing issue of critical drug shortages – the first Executive Order to directly affect FDA operations since 1985. In a coordinated move, FDA also released its report: "A Review …
By Kurt R. Karst – The first U.S. Conference on Rare Diseases and Orphan Products started with a bang today with the release of a landmark report announcing its findings of flexibility in FDA’s review of potential treatments for patients with rare (“orphan”) diseases. The conference, …
