Pharmaceutical & Medical Device Regulatory Update, Issue 3
Jones Day to Host Panel Discussions on New Frontiers in Health Care and Life Science
Top Stories
- Medical Device Recalls Increased by 97% Over 10-Year Period
- Senators, JAMA Weigh in on Mobile Medical Apps Regulation
- States Continue Protest Zohydro Approval; Massachusetts Bans Sales
- DEA Acts on FDA Proposed Rescheduling of Hydrocodone Combination Products
- FDA Considers Reforming Monograph System for OTC Drugs
- FDA Slow to Review Sunscreen Ingredient Applications
- More Clinical Trial Data May Become Available in Europe and the United States
Other News
- FDA Issues Guidance on Premarket Assessment of Pediatric Devices
- Supreme Court to Hear Appeal of Generic Multiple Sclerosis Drug Case
- FDA Publishes 35 Drug Safety Labeling Changes
- FDA Provides Update on Saline Drug Shortage
- FTC Seeks $1 Billion Settlement from Companies that Delay Generics
- MIT Chemists Speed Peptide Production for Faster Drug Development
- American Red Cross, Other Groups Urge FDA to Reconsider Rule Blocking Blood Donation by Gay Men
- FDA Advisory Panel Supports Non-Invasive Colon Cancer Test
- EU Investigates Safety of Vaginal Mesh Devices
- Brookings Institution Publishes Report on mHealth in China and the United States
- Researchers Find Wristband and Belt Activity Monitors Sense Only Some Movements
- NY Times Op-Ed Criticizes FDA's Position on Foreign Unapproved Drugs
Regulatory Updates
- FDA Proposes Rule on Medical Device Classification Procedures
- FDA Issues Standard Operating Procedure for Level I, Premarket Data
- FDA Requesting Nominations for Public Advisory Consumer Representatives
- FDA Issues Direct Final Rule on New Animal Drug Application Confidentiality
- FDA Issues Notices to Withdraw Approval of ANDAs for Certain Acetaminophen Drugs
- FDA Issues Draft Bioavailability and Bioequivalence Studies Guidance
Upcoming Meetings, Workshops, & Conferences
Enforcement Updates
Recent Product Recalls
Recent Warning Letters
Recent Drug and Device Approvals
