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, …
By Kurt R. Karst – Last week, Representative Michael McCaul (R-TX), along with Reps. G.K. Butterfield (D-NC), Sue Myrick (R-NC), and Chris Van Hollen (D-MD), introduced H.R. 3059, the Creating Hope Act of 2011. The bill is a companion bill to S. 606, which was introduced …
By Michelle L. Butler – On September 27th, FDA published a guidance document regarding user fee waivers, reductions, and refunds for drug and biological products. See 76 Fed. Reg. 59705 (Sept. 27, 2011); FDA, Guidance for Industry: User Fee Waivers, Reductions, and Refunds for Drug and …
By Anne Marie Murphy – FDA and the Office for Human Research Protections ("OHRP") have jointly announced the issuance of a draft guidance document on “Exculpatory Language in Informed Consent.” HHS and FDA regulations have long prohibited the use “exculpatory language” in informed consent documents for clinical research …
By Nisha P. Shah – The U.S. Department of Health and Human Services recently revised conflict of interest rules for Public Health Service ("PHS") related grants and research (i.e., the National Institutes of Health (“NIH”)) in response to congressional and public concerns over potential conflicts between …
By Kurt R. Karst – The National Organization for Rare Disorders (“NORD”) announced the submission of a Citizen Petition to FDA requesting “that a documented policy be established regarding the review of potential treatments for people with rare diseases.” The petition comes on the heels of …
By Kurt R. Karst – Last week, FDA issued its highly anticipated Proposed PDUFA V Reauthorization Performance Goals and Procedures for Fiscal Years 2013 through 2017, which were hammered out between FDA and industry after long negotiations. The proposal includes several new provisions compared to the …
By Kurt R. Karst – In a Report to Congress issued earlier this year and recently made public, FDA’s Rare Disease Group (“RDG”) and Neglected Tropical Disease Group (“NTDG”) report on their findings and recommendations to improve the current regulatory/scientific armamentarium to facilitate the development of …
By Anne Marie Murphy – This week FDA announced the publication of a draft guidance titled, “Oversight of Clinical Investigations: A Risk Based Approach to Monitoring.” This is the first time since 1988 that the agency issued a specific guidance document on how a study sponsor …
The American Conference Institute will be holding its 12th annual “Maximizing Pharmaceutical Patent Life Cycles” conference in New York City from October 3-5, 2011. A copy of the conference program is available here. Hyman, Phelps & McNamara, P.C.’s Kurt R. Karst will be presenting at …
By Cassandra A. Soltis & Anne Marie Murphy – The Department of Health and Human Services, Office of the Secretary, along with the Office of Science and Technology Policy, has issued an advance notice of proposed rulemaking (“ANPRM”) requesting comments on how to update current regulations on …
By Kurt R. Karst – Each year around this time, some of us at our firm participate in a version of The Price Is Right Showcase Showdown in which folks “bid” on what they think the PDUFA application user fee rate will be set at for …
By Nisha P. Shah – Under a bill titled, “An Act to Make Certain Prescription Drug Disclosure Laws Consistent with Federal Law,” the State of Maine repealed three laws related to the reporting of marketing costs, price reporting, and the disclosure of clinical trials by manufacturers …
