Pharmaceutical & Medical Device Regulatory Update, Issue 3

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

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