Latest Federal Register Notices

Comments Sought on FDA’s Focus Group Use 04/21/2017
Federal Register notice: FDA seeks comments on an information collection on “Focus Groups as Used by the Food and Drug Administration (all FDA- regulated products).”

Comments Sought on Dietary Supplement Recordkeeping 04/20/2017
Federal Register notice: FDA asks for comments on an information collection: “Current Good Manufacturing Practice in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements — 21 CFR Part 111.”

Imaging Drugs Panel to Review NX Development Imaging Agent 04/19/2017
Federal Register notice: FDA announces a 5/10 Medical Imaging Drugs Advisory Committee meeting that will discuss a NX Development Corp. NDA for a new imaging agent.

Oncologic Panel to Review to NDAs in May 04/19/2017
Federal Register notice: FDA announces a 5/24 Oncologic Drugs Advisory Committee meeting that will review two NDAs.

Hospira Epogen/Procrit Biosimilar Heads to Panel Meeting 04/19/2017
Federal Register notice: FDA announces a 5/25 Oncologic Drugs Advisory Committee meeting that will discuss a Hospira BLA for a proposed biosimilar product referencing Amgen’s Epogen/Procrit (epoetin alfa).

Public Workshop on Safe Opioid Prescribing 04/18/2017
Federal Register notice: FDA announces a 5/9-10 workshop to obtain input on issues and challenges associated with federal efforts to support training on pain management with opioids.