Enforcement Update – FDA OPDP Sends Two More Letters (Sep 20, 2019 04:44)
For those who like to keep up on the activity of the Office of Prescription Drug Promot...

HP&M Attorneys Recognized by LMG Life Sciences Awards (Sep 19, 2019 22:51)


FDA Finalizes Updates to the Special 510(k) Program (Sep 19, 2019 04:39)
By Adrienne R. Lenz, Senior Medical Device Regulation Expert —

Is California Dreamin? Reverse Payment Agreements Presumptively Anticompetitive (Sep 17, 2019 22:10)
By Sara W. Koblitz —

Petition to Prohibit the Use of “Uncured” and “No Nitrate or Nitrite Added” on Processed Products that Contain Nitrite/Nitrate from “Natural” Sources (Sep 16, 2019 22:32)
By Riëtte van Laack —

Compounded Hormone Replacement Products: FDA’s Latest “Statement” (?) Addressing Adverse Event Reporting (Sep 15, 2019 22:38)
By Karla L. Palmer —

CDRH Issues Final Guidance on De Novo Submission Acceptance Review (Sep 12, 2019 22:28)
By Rachael E. Hunt —

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