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…6 months of pediatric exclusivity (until June 2, 2013). FDA, following the explanation provided in the Agency’s March 27, 2012 Letter Decision, [http://www.hpm.com/pdf/blog/SEROQUEL%20-%20FDA%20Letter%20Decision%203-27-2012.pdf] primarily argued that the scope of 3-year…
…pledged that the frequency of these inspections would increase. The GMP by the Sea conference is a regular conference (it was held annually until COVID hit) sponsored by PharmaConference (www.pharmaconference.com)….
Sigh. We’ve been dragged (kicking and screaming) into the 21st Century. So, we’ve put down our quill pens and are now twittering at www.twitter.com/fdalawblog. Many of our “tweets” will link…
…petitioners. Now a new challenge to FDA’s restrictive treatment of health claims in foods and dietary supplements seeks to build on ANH’s success. In a recently filed complaint in the U.S….
…pharmacologic science as a basis for regulation affecting human safety and health, and the environment. The current ISRTP Council President is Hyman, Phelps & McNamara, P.C.’s Diane B. McColl. [http://www.hpm.com/vattorney.cfm?RID=27]…
…in 2019 that may shape future FDA regulation. We hope this report proves useful and interesting to you. For more information about HP&M, please go to our website at www.hpm.com….
By Kurt R. Karst – You know the drill . . . . One organization comes out with a report saying one thing supported by various data. Days later, another…
…loss-May cause seizures in patients with a seizure disorder www.nofocus.com/risk”. (Risk Guidance at 14). Six characters to spare! And this is a drug that has very few risks, apparently. Similarly,…
…oversee. Meanwhile, manufacturers are on the hunt to find their quarry before their customers do it for them. We’ll report back as this complex regulatory structure continues to take shape….
…before FDA is funded for Fiscal Year 2012. Several Senate amendments to H.R. 2112 were considered and rejected, including Sen. David Vitter’s (R-LA) Amendment No. 769 to permit individuals to…
…agents and private enforcers from requiring Prop. 65 warnings on foods that contain acrylamide. Plaintiff claims that the requirement for a Prop. 65 warning is illegal because it compels Plaintiff’s…
…is the apocalyptic decision made by the U.S. Supreme Court in PLIVA, Inc. v. Mensing, 131 S. Ct. 2567 (2011). Indeed, FDA says as much in the preamble to the…
…entry. Senior FDA officials have signaled that implementation of the new and enhanced enforcement authorities granted by the FSMA is a high priority. Their first use can’t be far behind….
…this brief provides the clearest statement of FDA’s limited authority to compel a recall. We previously described (here and here) the litigation commenced by Hospira, Inc. (“Hospira”) wherein the company…
…are living longer and facing the ailments so common to old age. Enter the FDA’s Center for Veterinary Medicine (“CVM”). A longstanding component of the FDA and its predecessor, CVM,…