Earlier this week, FDA announced the availability of a draft guidance for industry, titled “Bioequivalence Recommendations for Specific Products.” The draft guidance describes a new process by which FDA will provide, via the Internet, recommendations on how to design product-specific bioequivalence (“BE”) studies to support …
On May 10, 2007, FDA announced the availability of a draft guidance for industry –“Protecting the Rights, Safety, and Welfare of Study Subjects – Supervisory Responsibilities of Investigators.” The draft guidance document is intended to help investigators meet their responsibilities with respect to protecting human …
In a recently-released report on the pharmaceutical, biotech, and medical device industries’ relationship with FDA, a significant number of representatives surveyed responded that user fees have not succeeded in decreasing approval times. The report, “Improving America’s Health IV: A Survey of the Working Relationship between …
In the near future, one might see the following ad on Ebay or Craig’s List: "For Sale: One FDA Priority Review voucher. Mint condition. Entitles 505(b)(1) applicant to 6-month FDA review. Sponsor must pay additional user fee." In an effort to incentivize companies to invest in …
On May 2, 2007, FDA announced the availability of a report, titled “Critical Path Opportunities For Generic Drugs.” The report identifies several unanswered scientific questions that FDA believes impede the development of generic versions of commonly used brand name drugs, and is part of FDA’s …
On April 12, 2007, the Association of American Physicians & Surgeons (“AAPS”), Concerned Women for America, Family Research Council, and Safe Drugs For Women filed a complaint in the U.S. District Court for the District of Columbia against FDA seeking declaratory and injunctive relief concerning …
“Orphan drugs” are products recognized by FDA that are intended for use in a “rare disease or condition” ─generally a disease or condition with a United States prevalence less than 200,000 persons. Because the market for orphan drugs is often limited, Congress and FDA have …
On March 12, 2007, Greenberg Traurig submitted a citizen petition to FDA to switch four prescription antihistamine and antihistamine-decongestant drugs from prescription to OTC status. The four drugs are ALLEGRA (fexofenidine HCl), ALLEGRA D (fexofenidine HCl; pseudoephedrine HCl), ZYRTEC (cetirizine HCl), and ZYRTEC D (cetirizine …
On March 1, 2007, the District of Columbia Circuit Court of Appeals heard an oral argument in Abigail Alliance v. von Eschenbach. Previously, a divided court of appeals had ruled that where there are no other FDA-approved treatment options, a terminally ill patient’s access to …
