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- FDA Issues Draft Guidance on Analgesic Indications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- FDA Issues Draft Guidance on Section 745A(a) Electronic Submissions
- FDA Issues Revised Draft Guidance on Submitting Standardized Study Data in Electronic Submissions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
