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"FDA Issues Draft Guidance on Analgesic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"FDA Issues Draft Guidance on Section 745A(a) Electronic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"FDA Issues Revised Draft Guidance on Submitting Standardized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"
View the newsletter here.
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.