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"FDA Issues Draft Guidance on Analgesic Indications"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"FDA Issues Draft Guidance on Section 745A(a) Electronic Submissions"
"FDA Issues Revised Draft Guidance on Submitting Standardized Study Data in Electronic Submissions"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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The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.