Pharmaceutical & Medical Device Regulatory Update - March 2014

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Jones Day

Contributor

Jones Day is a global law firm with more than 2,500 lawyers across five continents. The Firm is distinguished by a singular tradition of client service; the mutual commitment to, and the seamless collaboration of, a true partnership; formidable legal talent across multiple disciplines and jurisdictions; and shared professional values that focus on client needs.
Jones Day to Host Panel Discussions on New Frontiers in Health Care and Life Science
United States Food, Drugs, Healthcare, Life Sciences

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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