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 Kurt R. Karst – With each stroke of the pens President Obama used to sign into law the Leahy-Smith America Invents Act, it seemed as though another nail was hammered into the coffin of any attempts to deny The Medicines Company (“MDCO”) a win in …
By Kurt R. Karst – Generic Pharmaceutical Association (“GPhA”) Board of Directors Chairman Paul Bisaro recently sent a letter to members announcing both the completion of the negotiating phase (see here and here) of what is intended to become the Generic Drug User Fee Act (“GDUFA”) …
By Kurt R. Karst – On September 19th, FDA announced the issuance of a revised version of the Agency’s June 2006 final guidance document/Compliance Policy Guide (“CPG”) (FDA Docket No. 2003D-0478), titled “Marketed Unapproved Drugs – Compliance Policy Guide Sec. 440.100, Marketed New Drugs Without Approved …
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Anne Marie Murphy – FDA and the Office for Human Research Protections ("OHRP") have jointly announced the issuance of a draft guidance document on “Exculpatory Language in Informed Consent.”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 Karla L. Palmer & Jeffrey N. Gibbs – Marking a significant victory for the pharmaceutical compounding industry, a Florida federal district court ruled that FDA did not have authority to enjoin the “long-standing, widespread, state-regulated practice of pharmacists filling a veterinarian’s prescription for a non-food …
By Susan J. Matthees – The Center for Inquiry, a non-profit organization with a mission to “promote scientific inquiry,” recently submitted a Citizen Petition to FDA requesting that the Agency initiate rulemaking for a proposed rule that would require all homeopathic drugs to be tested for …
By Kurt R. Karst – September 12th marked the beginning of the eighth round of Trans-Pacific Partnership (“TPP”) negotiations, which are taking place in Chicago, Illinois. The TPP is an Asia-Pacific regional trade agreement being hammered out among the United States and eight other partners. The …
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 – On September 8th, the U.S. Senate passed, by an 89-9 vote, H.R. 1249, the Leahy-Smith America Invents Act. Final passage of the bill, which will make significant changes to the U.S. patent system, was preceded by a contentious vote on, you …
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 – A recent Citizen Petition submitted on behalf of Abbott Laboratories (“Abbott”) calls into question FDA’s authority for granting Therapeutic Equivalence (“TE”) ratings (i.e., “A” ratings) for drug products approved pursuant to FDC Act § 505(b)(2). Specifically, Abbott’s petition requests that FDA …
By Kurt R. Karst – In what appears to be the first instance in which a court has considered the U.S. Supreme Court’s decision in PLIVA, Inc. v. Mensing in the context of a preemption defense in a state tort-law failure-to-warn case, Nevada State Court Judge Jerry …
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 …
