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…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]…
…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,…
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…
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…
…outside counsel, distinguished in-house counsel and compliance officers, as well as 9 government enforcers and regulators. They will help those in attendance: REASSESS compliance programs as a result of the…
…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….
…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)….
…kindly promoted FDA Law Blog. We look forward to the continuing success of FDA Law Blog. We encourage you to email us (jwasserstein@hpm.com or kkarst@hpm.com) with your comments and suggestions….
…products not currently marketed. A company called ANDA Repository, LLC (info@andarepository.com) is offering what we can only characterize as “ANDA arbitrage.” Imagine, if you will, a parking lot. The owner…
…“combat . . . the coronavirus.” Complaint at 6. The company further represented that such COVID-19-related benefits were clinically or scientifically proven. Id. at 5. The making, dissemination, and advertising…
…is competitive and commensurate with experience. HP&M is an equal opportunity employer. Please send your curriculum vitae, transcript, and a writing sample to Anne K. Walsh (awalsh@hpm.com). Candidates must be…
…firm experience, including litigation experience, and a federal judicial clerkship. E-discovery expertise is a bonus. Compensation is competitive and commensurate with experience. HP&M is an equal opportunity employer. Please send…
…will be considered “initiated” prior to the compliance date, and the new statement will not be required in the informed consent documents. Guidance, p. 4. FDA also explains that any…
…involving restricted distribution products – Actelion Pharm. Ltd. v. Apotex, Inc., Case No. 12-5743 (D.N.J.) (see our previous posts here, here, and here) and Lannett Co., Inc. v. Celgene Corp.,…
By James C. Shehan & David B. Clissold – Good brand names have been important to drug marketers as far back as Biblical times – the Book of Ecclesiastes tells…