Pharmaceutical & Medical Device Regulatory Update, Issue 1

Pharmaceutical & Medical Device Regulatory Update, Issue 1

In this issue:

Top Stories

  • FDA Memorandum Outlines Significant Overhaul of Inspection and Compliance Processes
  • FDA Concerned Over Safety of Drugs Manufactured in India
  • CBER and CDER Publish 2014 Guidance Agendas
  • CDRH Releases 2014–2015 Strategic Priorities Report
  • CDER Official Testifies Before Congress on Drug Shortages

Regulatory Updates

  • FDA Issues Guidance on Annual Reports for Approved PMAs
  • FDA Issues Draft Guidance on Analgesic Indications
  • FDA Issues Final Rule and Guidance on Electronic Medical Device Reporting
  • FDA Issues Guidance on Receipt Date of Electronic Submissions
  • FDA Issues Draft Guidance on Section 745A(a) Electronic Submissions
  • FDA Issues Revised Draft Guidance on Submitting Standardized Study Data in Electronic Submissions
  • FDA Issues Proposed Rule and Direct Final Rule on Maximum CMPs
  • FDA Publishes Modifications to List of Standards Recognition List
  • FDA Requests Nominations to the FDA Science Board
  • FDA Classifies EEG Assessment Aid as Class II

Upcoming Meetings, Workshops, and Conferences

Enforcement Updates

  • Recent Product Recalls
  • Recent Warning Letters
  • Recent Drug and Device Approvals

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