A year ago, we blogged about a proposed rule that would replace the Quality System Regulation (QSR) at 21 C.F.R. Part 820 with a newly named Quality Management System Regulation (QMSR) (see here). The proposed rule was published on February 23, 2022 and was first …
FDA uses its Product Specific Guidance documents (“PSGs”) to provide recommendations as to the bioequivalence testing necessary for approval of a generic drug. As the Office of Generic Drugs (“OGD”) has stated, “[t]he clarity and transparency provided by PSGs help streamline generic drug product development, …
As of the morning of March 1, the hotly anticipated Joint Meeting of the Nonprescription Drugs Advisory Committee and the Anesthetic and Analgesic Drug Products Advisory Committee originally scheduled for March 20 has been cancelled. The March 20 Joint Meeting concerned the NDA for naloxone …
In January 2023, FDA published a paper summarizing its lessons learned from two pilot Quality Management Maturity (QMM) Pilot Programs, such as best practices for conducting QMM assessments and developing the QMM scoring system. The lessons learned were also discussed during a November 2022 workshop …
Since 2005, 510(k) submissions have been formatted according to FDA guidance Format for Traditional and Abbreviated 510(k)s. The guidance describes twenty sections to be included in a Traditional or Abbreviated 510(k). With 18 years’ experience, we have developed a pretty good system for preparing 510(k) …
The Drug Enforcement Administration’s (“DEA’s”) February 13th determination that THC acetate ester (“THCO”) is a schedule I controlled substance under the federal Controlled Substances Act (“CSA”) has received a good amount of attention in the cannabis press. That determination, however, was neither a stretch nor a …
The FDA Alumni Association (FDAAA) named Hyman, Phelps & McNamara, P.C.’s Director Deb Livornese as its 2022 Volunteer of the Year for her remarkable leadership steering its Activities Committee through COVID and many new challenges. The FDAAA, whose members are FDA alumni and current employees, helps …
