Last week, I presented at the Center for Business Intelligence’s Pharmaceutical Congress on Paragraph IV Disputes with Geoff Levitt of Wyeth on citizen petitions. The focus of my talk was on new FDC Act § 505(q) – “Petitions and Civil Actions Regarding Approval of Certain …
On October 20, 2008, FDA announced the availability of a highly anticipated draft guidance document, titled “Tropical Disease Priority Review Vouchers.” The draft guidance discusses FDA’s implementation of FDC Act § 524 – “Priority Review to Encourage Treatments for Tropical Diseases” – which was added …
FDA’s Office of Combination Products (“OCP”) recently released a draft guidance entitled “New Contrast Imaging Indication Considerations for Devices and Approved Drug and Biological Products.” The draft guidance permits diagnostic imaging device makers to expand labeling for use with a contrast agent or radiopharmaceutical even …
FDA recently published a new draft guidance document on potency tests for cellular and gene therapy (“CGT”) products. The FDC Act requires that all biological products meet agency requirements for safety, purity, and potency before such products will be approved, but historically the agency and …
On October 2, 2008, the Consumer Product Safety Commission (“CPSC”) held a public meeting on the testing and certification requirements imposed by the recently enacted Consumer Product Safety Improvement Act (“CPSIA”). A similar meeting was held on September 4, 2008 and several others are planned …
In a surprising and likely controversial decision regarding so-called “Section 340B covered entities,” the U.S. Court of Appeals for the Ninth Circuit in County of Santa Clara v. Astra U.S.A., Inc. recently reversed the U.S. District Court for the Northern District of California’s dismissal of …
Earlier this week, Senator Sherrod Brown (D-OH) announced the introduction of S. 3633, the “Transparency in Drug Labeling Act.” The bill, also know as the “COOL Pharmaceutical Bill,” would amend the FDC Act to require Country-Of-Origin (“COO”) labeling on prescription and Over-The-Counter (“OTC”) drug products. …
Section 920 of the FDA Amendments Act (“FDAAA”) amended the FDC Act to create new § 505(t) – “Database for Authorized Generic Drugs” – that requires FDA to compile and publish a complete list of all authorized generic drugs identified in annual reports submitted to …
We previously reported that it has been unclear whether a company submitting an ANDA containing the results of an in vivo bioequivalence study must certify on Form FDA 3674 that new Public Health Service Act (“PHS Act”) § 402(j), as added by Title VIII of the …
Human history is replete with examples of the use of lethal or debilitating agents in war and by terrorists. As early as the 6th Century B.C., the Assyrians are reported to have poisoned the wells of their enemies with ergot of rye (causing ergotism), and …
On March 5, 2008, FDA published a notice in the Federal Register announcing an opportunity for public comment on a proposed collection of information concerning the new clinical trial certification requirement created by Title VIII of the FDA Amendments Act (“FDAAA”). We previously reported on …
In recent years, FDA has studiously avoided taking any broad regulatory action on the issue of whether, and under what circumstances, the presence of methylmercury in fish renders that fish adulterated. FDA recognized that the scientific evidence that addresses the potential risks posed by methylmercury …
FDA released a Memorandum of Agreement Between the Office of New Drugs (“OND”) and the Office of Surveillance and Epidemiology (“OSE”) in the Center for Drug Evaluation and Research (“CDER”) “on the management of significant safety issues associated with pending and approved drug products.” The …
As we previously reported, in August 2007, FDA issued a letter and started a docket requesting public comment on a variety of 3-year exclusivity issues concerning generic versions of Shire U.S. Inc.’s PROAMATINE (midodrine hydrochloride) Tablets. FDA approved PROAMATINE in September 1996 under the Agency’s …
Now that FDA has set the Fiscal Year 2009 Prescription Drug User Fee Act (“PDUFA”) user fee rates and is preparing invoices for delivery (payable by October 1, 2008), a quick review of the options available to companies to request user fee waivers and reductions …
