By Jamie K. Wolszon & Jeffrey N. Gibbs – On November 6, Alberto Gutierrez, the head of the office in charge of regulating in vitro diagnostics at FDA’s Center for Devices and Radiological Health (CDRH), discussed the two Laboratory-Developed Test (LDT) draft guidances with members of …
Hyman, Phelps & McNamara, P.C. has once again been ranked as a “Tier 1” law firm in the area of “FDA Law” (both nationally and in Washington, D.C.) by the folks over at U.S. News & World Report, who teamed up with Best Lawyers for …
By Allyson B. Mullen – On November 3, 2014, the law firm of McKenna Long & Aldridge LLP filed suit on behalf of Plymouth Direct, Inc. (Plymouth) and Natures Pillows, Inc. (NPI) in the United States District Court for the District of Columbia against FDA claiming …
By Kurt R. Karst – We learned this week that FDA finally approved ANDAs for generic versions of Hoffmann-LaRoche, Inc.’s VALCYTE (valganciclovir) Tablets, 450 mg (NDA 021304). We don’t usually post on FDA’s daily ANDA approval activities, but the valganciclovir ANDA approvals are …
By Kurt R. Karst – Last week when this blogger reported on the lawsuit filed by Amgen, Inc. (“Amgen”) in the U.S. District Court for the Northern District of California alleging that Sandoz Inc. (“Sandoz”), in its efforts to obtain approval of a Section 351(k) application …
By Michelle L. Butler & Kurt R. Karst – On November 3, 2014, just short of the 60-day deadline, FDA filed a notice appealing to the U.S. Court of Appeals for the District of Columbia Circuit the Final Judgment and Order entered on September 5, 2014 …
By Jennifer D. Newberger & Alan M. Kirschenbaum – On October 31, 2014, the Centers for Medicare & Medicaid Services ("CMS") finalized changes to the regulations implementing the Affordable Care Act’s transparency reporting provisions, otherwise known as the Physician Payment Sunshine Act ("Sunshine Act"). The original Sunshine …
By Wes Siegner – In the October 30 Federal Register, FDA announced that it will hold a public meeting on December 9 to consider significant changes to its guidance titled “Toxicological Principles for the Safety Assessment of Food Ingredients,” or “Redbook”. FDA also invited comment to …
By Alexander J. Varond – In one of the clearest signs that the U.S. Consumer Product Safety Commission ("CPSC") is stepping up enforcement of CPSC requirements, the Commission recently announced that it had reached a record $4.3 million civil penalty settlement with Baja Inc., and its …
