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…et. al., 529 U.S. 120, 161 (2000). Congress granted FDA that authority last year in the Family Smoking Prevention and Tobacco Control Act. The act explicitly ordered FDA to re-issue…
…the product . . . is the first permitted commercial marketing or use of the product under the provision of law under which such regulatory review period occurred.” While Plaintiffs…
…DoJ may come knocking. And, as companies prepare their comments on the draft guidance, they should be aware that the stakes could be much higher than receiving a Warning Letter….
…LLC) from introducing into interstate commerce any unapproved drug, among other requested relief. The Complaint was filed after the company allegedly failed to stop marketing its over-the-counter product Viruxo Immune…
…To, Certain Antibiotics” – of the “QI Program Supplemental Funding Act of 2008” (Pub. L. No. 110-379) (see our previous post here). We now have a new date to add…
By Karla L. Palmer – The Senate passed a bill last Thursday, December 11, 2014, that will prohibit the use of certain designer anabolic steroids. H.R. 4771, titled the Designer…
…“runs counter to the way Congress has used the phrase ‘a drug designated . . . for a rare disease or condition’” elsewhere throughout the U.S. Code. Slip. Op. at…
…manufacturer’s promotional activities. See Pacira Pharms., Inc. v. FDA, No. 15-7055 (S.D.N.Y. Sept. 8, 2015). Pacira’s allegations are based on FDA’s threatened enforcement as communicated in a September 22, 2014…
…Conditions with GFI #209. Based on recommendations in this guidance, all production uses (i.e., non-therapeutic uses) of medically important antimicrobials were eliminated. As CVM mentions in its press release, this…
…and combination products. Dr. Cho graduated from the Vanderbilt University Law School, and earned her Ph.D. at the University of Chicago. She has a Bachelor of Arts from Smith College….
By John A. Gilbert & Karla L. Palmer – On October 12th, President Obama signed into law the “Combat Methamphetamine Enhancement Act of 2010” (Public Law No: 111-268) (“Enhancement Act”). …
…its easy availability.” Dextromethorphan is an antitussive (i.e., cough suppressant) found alone or in combination with other drugs in over 120 over-the-counter cough and cold products. Dextromethorphan is not a…
By John A. Gilbert, Jr. & Larry K. Houck – In separate notices published today, the Drug Enforcement Administration (“DEA”) issued three major decisions on marijuana and industrial hemp. The…
…and other agencies. Adrienne R. Lenz joined HP&M as a Senior Medical Device Regulation Expert. Adrienne Lenz provides consulting to medical device and combination product manufacturers. Ms. Lenz assists clients…
…to come into compliance. What will ultimately happen to the TA or other IVD legislation is uncertain. Clearly, a new law will not be enacted this year. Given the competing…