Insights

Pharmaceutical & Medical Device Regulatory Update, Issue 2

Pharmaceutical & Medical Device Regulatory Update, Issue 2

Jones Day to Host FDLI Drug Law and Regulation Conference

Top Stories

  • Draft Guidance Promises Major Changes in New Chemical Entity Exclusivity Provisions
  • President Proposes 8 Percent Increase for FDA's Budget
  • Senator Proposes Bill to Reverse Approval of Hydrocodone Drug
  • Group of Generic Drug Manufacturers Opposes Labeling Proposal
  • New "openFDA" Project Revamps Public Data on Drug Side Effects
  • FDA and European Medicines Agency Strengthen Collaboration in Medicine Safety

Other News

  • FDA Commissioner Hamburg testifies at Senate hearing about mechanisms to streamline CDRH review of medical device applications.
  • FDA announces April 1 public hearing on action plan for gathering and analyzing demographic subgroup data for approval of medical products.
  • FDA initiates the Secure Supply Chain Pilot Program to enhance security of imported drugs.
  • FDA considers fertility method involving mitochondrial combination.
  • Federal advisory committee recommends DNA test replace traditional pap smear as primary screening tool for cervical cancer.

Regulatory Updates

FDA Issued Rules or Guidance on the Following Topics:

  • FDA Issued Guidance on Administrative Procedures for CLIA Categorization
  • FDA Issued Proposed Orders or Draft Guidance on Enforcement Policy for Fecal Microbiota Uses

FDA published the following Federal Register Notices Regarding Agency Information Collection Activities:

  • Approval for collection of information on Over-the-Counter Human Drugs; Labeling Requirements.
  • Approval for collection of information on Medical Devices; Third Party Review Under the Food and Drug Administration Modernization Act (FDAMA).
  • Approval for collection of information on Human Tissue Intended for Transplantation.
  • Opportunity for comment on proposed collection of information on paperwork burden of recordkeeping by institutional review boards reviewing clinical research studies (comments due April 3).
  • Opportunity for comment on proposed collection of information on paperwork burden of donor screening recommendations for serological test systems for the detection of antibodies to Trypanosoma cruzi (comments due April 4).
  • Opportunity for comment on proposed collection of information on guidance regarding citizen petitions and petitions for stay of agency action (comments due April 10).
  • Opportunity for comment on proposed collection of information on paperwork burden of importer's entry notices for FDA-regulated products (comments due April 14).
  • Opportunity for comment on proposed collection of information on required disclosures for direct-to-consumer prescription drug TV advertisements (comments due April 21).
  • Opportunity for comment on proposed collection of information on paperwork burden of animal drug sponsors filling out the Animal Generic Drug User Fee Act (AGDUFA) cover sheet (comments due April 21).
  • Opportunity for comment on proposed collection of information on reporting requirements for prescription drug advertisements (comments due April 28).
  • Opportunity for comment on proposed collection of information on User Fee Waivers, Reductions, and Refunds for Drug and Biological Products (comments due May 5).

Upcoming Meetings, Workshops, and Conferences


Enforcement Updates

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