By Kurt R. Karst – In a notice that will publish in the Federal Register later this week, FDA, citing safety concerns, will announce the Agency’s plans to take enforcement action against all unapproved single-ingredient, immediate-release human drug products containing Oxycodone HCl for oral administration, and …
By Jamie K. Wolszon – Five years ago, Congress passed the FDA Amendments Act of 2007 (“FDAAA”), requiring FDA to promulgate regulations establishing a Unique Device Identifier (“UDI”) system to facilitate adverse event and recall tracking. Under FDAAA, the UDI regulations must require an identifier on …
By Ricardo Carvajal – We raised this question at the recent ABA Section of Litigation Food & Supplements Second Annual Workshop as a way of commenting on emerging threads of resistance to the imposition of greater food safety-related requirements at all levels of government, but especially …
By Ricardo Carvajal – In several letters issued to trade associations on June 18th (for an example, see here), FDA stated that it “will expect to enforce compliance” with the preventive controls provision in section 103 of the Food Safety Modernization Act ("FSMA") and the foreign …
By JP Ellison & Jennifer M. Thomas – If you have ever sat in a meeting, received a letter or brief, or otherwise heard an interpretation from a regulatory agency that surprised, confounded or frustrated you, then you should read the Supreme Court’s recent decisions in …
By Kurt R. Karst – Earlier this week, the Presidential Commission for the Study of Bioethical Issues (“Commission”) announced in a Federal Register notice that it is seeking comment on several ethical issues associated with the development of medical countermeasures for children. The announcement …
By John A. Gilbert, Karla L. Palmer & Larry K. Houck – The Food and Drug Administration Safety and Innovation Act (“FDASIA”) (S. 3187), which is on its way to the President for enactment after the Senate passed the bill by a 92-4 vote, may impact …
By Kurt R. Karst – We’ve been wondering for a while now when FDA might be asked in a public forum to decide on the issue of whether a “first applicant” eligible for a period of 180-day generic drug marketing exclusivity has forfeited such eligibility if …
By Kurt R. Karst – In a June 25th decision from Judge Amy Berman Jackson of the U.S. District Court for the District of Columbia, the court gave a mixed bag ruling on Cross-Motions for Summary Judgment (here and here) filed by FDA …
By Kurt R. Karst – Nearly seven years after having received a citizen petition (FDA Docket No. FDA-2005-P-0120) requesting that FDA apply more stringent and unconventional bioequivalence requirements (and twice supplemented – here and here – along the way) before approving generic versions of ADDERALL XR …
By Kurt R. Karst – We’re always interested in cases where things, at first glance, just don’t seem to add up. If we cannot find an explanation, we may put the case to the side for a while, and wait until an explanation becomes available. That’s …
Hyman, Phelps & McNamara, P.C. Director Douglas B. Farquhar is a key presenter at the Food and Drug Law Institute’s (“FDLI’s”) upcoming conference in São Paulo, Brazil. The conference, which is scheduled for September 10-11, 2012, is titled “U.S. & Brazil: Navigating New Frontiers in …
By Kurt R. Karst – Over the past year or so, we’ve seen a change in FDA policy concerning what approvals the sponsor of a 505(b)(2) NDA can cite in an application; that is, what previous FDA approvals a 505(b)(2) sponsor can rely on for the …
By Ricardo Carvajal – In a relatively rare example of a request for regulatory action intended to benefit a specific racial or ethnic group, a coalition of businesses and nonprofits submitted a food additive petition (see here and here) asking FDA to amend the food additive regulation …
By Kurt R. Karst – A new article, titled “Citizen Petitions: An Empirical Study,” analyzes citizen petitions submitted to FDA between 2001 and 2010 and concludes that petitions submitted to FDA concerning drug products are on the rise and show no signs of abating. The paper, …
