Regulatory Focus™ > News Articles > Regulatory Recon: After 12 Years, FDA Finally Releases Rule on Generic Drugs (6 February 2015)

Regulatory Recon: After 12 Years, FDA Finally Releases Rule on Generic Drugs (6 February 2015)

Posted 06 February 2015 | By Alexander Gaffney, RAC 

Regulatory Recon: After 12 Years, FDA Finally Releases Rule on Generic Drugs (6 February 2015)

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.

In Focus: US

  • FDA’s ‘Monster’ Proposed Rule Targets Patent Use Codes, Paragraph IV Certification (Pink Sheet-$) (FDA) (Law 360-$) (FDA Law Blog)
  • Pew, Other Groups Identify Potential Measures to Address Drug Shortages (Pew)
  • DEA Scheduling Reform Bill Advances in the House (E&C)
  • Thanks to FDASIA: Numbers of Drug Shortages Falling, FDA Says (RPM First Take)
  • Hospira issues another recall even as Pfizer announces buyout deal (Fierce)
  • DOJ issues permanent injunction against German devicemaker for violating FDA regs (Fierce)
  • Experts: FDA’s Draft on Combo Products CGMP Helpful (MDDI)

In Focus: International

  • Council of EU breaks device texts into bite-sized pieces in bid to reap results (Clinica-$)
  • Concept paper on the revision of annex 1 of the guidelines on good manufacturing practice – manufacture of sterile medicinal products (EMA)
  • European Commission approves added indication for Janssen’s Velcade, in MCL (PharmaLetter-$)
  • CAPA Should Not Be a Dreaded Four-Letter Word (MasterControl)

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  • Join RAPS, Wednesday, 18 February for New China Medical Device Regulations: Best Practices for Clinical Trials.

US: Pharmaceuticals and Biotechnology

  • FDA’s ‘Monster’ Proposed Rule Targets Patent Use Codes, Paragraph IV Certification (Pink Sheet-$) (FDA) (Law 360-$) (FDA Law Blog)
  • Pew, Other Groups Identify Potential Measures to Address Drug Shortages (Pew)
  • DEA Scheduling Reform Bill Advances in the House (E&C)
  • Thanks to FDASIA: Numbers of Drug Shortages Falling, FDA Says (RPM First Take)
  • Hospira issues another recall even as Pfizer announces buyout deal (Fierce)
  • Non-Clinical Cardiovascular Safety Testing: Moving Forward (FDA-PDF)
  • A US Regulator’s View on Abuse Deterrent Formulations of Opioids (FDA-PDF)
  • Sunscreen TEA Advocates Want Help Scaling FDA’s ‘High Bar’ For OTC Monographs (Tan Sheet-$)
  • FDA bioresearch 483s in India dip (SCRIP-$)
  • Background Analysis: US FDA Joint Advisory Committee to Review Avedro’s VibeX/KXL System to Treat Rare Corneal Disorder Following LASIK – FEB 24, 2015 (Tarius)
  • FDA AdComm to Review Organon's Sugammadex NDA (Tarius)

US: Pharmaceuticals and Biotechnology: Clinical Study Results, Filings and Designations

  • BLA for CSL Behring's Investigational Hemophilia B Drug Accepted for Review (MPR)
  • FDA Accepts Actavis' sNDA for Teflaro Labeling Expansion (Press)
  • GSK announces positive overall survival results from phase III COMBI-d study of dabrafenib (Tafinlar) and trametinib (Mekinist) combination (Press)

US: Pharmaceuticals and Biotechnology: General

  • Arkansas Reaches Settlement in Cystic Fibrosis Drug Suit (WSJ-$)
  • White House stresses treatment in new $133M fight against drugs (The Hill)

US: Medical Devices

  • DOJ issues permanent injunction against German devicemaker for violating FDA regs (Fierce)
  • Experts: FDA’s Draft on Combo Products CGMP Helpful (MDDI)
  • Pelvic mesh lawsuits: Judge urges plaintiffs, medtech companies to settle (Mass Device) (Reuters)
  • Fresenius Kabi Begins Clinical Trial of the Fenwal Amicus Red Blood Cell Exchange System to Treat Sickle Cell Disease (Press)

US: Dietary Supplements

  • NIH Office of Dietary Supplements Releases 2015-20 Strategic Plan (NIH)

US: Assorted And Government

  • Bill aims to stop sue-and-settle regulation (The Hill)
  • Senate Dems Want More Money for NIH Research (Senate)

Upcoming Meetings

Ebola Outbreak

  • Ebola Drug Study Canceled (AP)

Europe

  • Council of EU breaks device texts into bite-sized pieces in bid to reap results (Clinica-$)
  • Concept paper on the revision of annex 1 of the guidelines on good manufacturing practice – manufacture of sterile medicinal products (EMA)
  • European Commission approves added indication for Janssen’s Velcade, in MCL (PharmaLetter-$)
  • IQWiG sees benefits for Triumeq and Eperzan (PharmaLetter-$)
  • IQWiG finds no added benefit for Latuda in schizophrenia (PharmaLetter-$)

Japan

  • Sorin Group Receives Regulatory Approval for New Generation MRI Compatible Pacing System in Japan (Press)

Canada

  • Health Canada Investigating Claim Many Herbal Supplements Are Fake (HuffPo)

Other International

  • Tarius Launches New Translation Service for Small Device Companies (Tarius)

General Regulatory And Interesting Articles

  • CAPA Should Not Be a Dreaded Four-Letter Word (MasterControl)
  • New drug delivery device 'could transform cancer treatment' (MNT)

Regulatory Reconnaissance #488 – 6 February 2015

Regulatory Reconnaissance is our daily intelligence briefing for the regulatory affairs space, bringing you the top regulatory news stories from around the globe. Each weekday morning, we aim to bring you the latest highlights of new approvals, meetings, legal and political developments, regulations and guidance, and the latest trends with the potential to impact regulatory affairs professionals and the industry in which they work.

Need to contact the editor of Regulatory Reconnaissance? Find him on Twitter at @AlecGaffney or send him an email at news@raps.org.

A story's inclusion in Regulatory Reconnaissance does not imply endorsement by Regulatory Focus or RAPS.


Categories: Recon, Regulatory News

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