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…integrated health care delivery system in the U.S., submitted a citizen petition on December 22, 2009 requesting FDA take several actions in order to mitigate concerns it has with FDA’s…
On January 14, 2008, Nu-Pharm Inc., a Canadian drug company formerly owned by Apotex, Inc., filed a complaint in the U.S. District Court for the District of Columbia against FDA…
…in December 2007, but is covered by a period of pediatric exclusivity scheduled to expire on June 29, 2008. Since the April 11, 2008 order, companies with a stake in…
…reported, on September 12, 2008 (the same day that oral argument was heard), a 3-judge panel of Circuit Judges Brown, Kavanaugh, and Senior Circuit Judge Williams filed a per curiam…
…retailer QVC, Inc. The Consent Decree stems from a June 14, 2000 Federal Trade Commission (“FTC”) decision and order in which the Commission ordered QVC to cease representing certain products…
…of August 12, 2006, thirty months had passed from the date Teva submitted its ANDA for generic Cozaar. And as of January 16, 2007, thirty months had passed from the…
…remanding the case to the PTO for further consideration, the PTO, on March 19, 2010, once again denied MDCO’s PTE application in a 15-page decision (accompanied by more than 300 pages…
…summary, the district court dismissed PhRMA’s original Complaint on procedural grounds, without prejudice, granting PhRMA leave to amend its Complaint within 30 days. Granting, in part, California’s Motion to Dismiss,…
…IV Commitment Letter were relatively minor appeared to have been addressed in the September 2017 version of the guidance. In addition, the MDUFA IV Commitment Letter stated, “FDA will continue…
…for an individually identified patient. Section 503A has always permitted compounders to compound copies of shortage medications (which are not, by definition, “essential copies” of commercially available drug products). Never…
Hyman, Phelps & McNamara, P.C. is co-hosting a complimentary webinar, with Five Rivers Rx, on DEA compliance during the current opioid epidemic. The webinar is scheduled for November 15, 2018…
By Kurt R. Karst – An April 21st letter penned by David Balto, a Senior Fellow at American Progress who focuses on competition policy, intellectual property law and health care,…
…other, legitimate purposes (see, e.g., United States v. Borrasi, 639 F.3d 774 (7th Cir. 2011), here, and United States v. Greber, 760 F.2d 68, 71 (3d Cir.), cert. denied, 474…
…accuracy concerns, Washington Post, Apr. 19, 2020; Zachary Brennan & David Lim, FDA pushed through scores of inaccurate antibody tests without agency review, Politico, Apr. 27, 2020; Thomas Burton, FDA…
As we previously reported, the Made in the USA claim, as a voluntary claim on consumer goods, including products under FDA jurisdiction such as foods, over-the-counter drugs, and cosmetics, continues…