Regulatory Focus™ > News Articles > Regulatory Reconnaissance: FDA to Overhaul OTC Drug Approval Pathway (21 February 2014)

Regulatory Reconnaissance: FDA to Overhaul OTC Drug Approval Pathway (21 February 2014)

Posted 21 February 2014 | By Alexander Gaffney, RAC

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In Focus: US

  • FDA to Revamp Approval Path for OTC Drugs (WSJ-$) (FDA)
  • More Guidance on the Way from Office of Generic Drugs, and Other Nuggets (Lachman)
  • Hamburg, Goodman on the Safety of Foreign-Made Medicines (DR Show)
  • Generic "Application Chain Integrity" Should Be Sponsor Focus, FDA Says (Pink Sheet-$)
  • FDA Considers Trials of 'Three-Parent Embryos' (Science)
  • FDA Publishes DQSA Implementation and Guidance Timeline (Tracelink) (FDA)
  • Endo Puts Aside $520M For Vaginal Mesh Litigation (Law 360-$)
  • Report: FDA panel recommends Inspire Medical's sleep apnea implant (Mass Device)

In Focus: International

  • CHMP Approves Ten New Medicines for Approval (EMA) (Teva) (GSK) (Reuters) (SCRIP-$) (Bloomberg)
  • Another Breast Implant Recall in France, Australia (TGA)
  • UL Allies With India Group To Teach U.S. FDA Compliance To Local Makers (PharmAsia-$)
  • Excipient makers jump on audits as new regs kick in (Fierce)
  • Australia to adopt EMA's monoclonal antibody guideline (GABI)

US: Pharmaceuticals/Biotechnology

  • FDA to Revamp Approval Path for OTC Drugs (WSJ-$) (FDA)
  • More Guidance on the Way from Office of Generic Drugs, and Other Nuggets (Lachman)
  • Hamburg, Goodman on the Safety of Foreign-Made Medicines (DR Show)
  • Generic "Application Chain Integrity" Should Be Sponsor Focus, FDA Says (Pink Sheet-$)
  • FDA Considers Trials of 'Three-Parent Embryos' (Science)
  • Public interest groups call on FDA to reject genetically modified humans (MNT)
  • FDA Publishes DQSA Implementation and Guidance Timeline (Tracelink) (FDA)
  • FDA: Policies and Procedures for Proposed Trial Design Aimed at Multiple Chronic Conditions (Policy and Medicine)
  • 2014: The Year for FDA Guidance on Social Media (InTouchSol)
  • Maybe There Is Such a Thing As a Free Lunch - Vermont Considers Allowing Drug and Device Makers to Again Provide In-Office Meals to Healthcare Professionals (FDA Law Blog)
  • J&J Blood Thinner Xarelto Caused Bleeding, Suit Says (Law 360-$)
  • Fed. Circ. Nixes Win For Takeda In Generic Prevacid Case (Law 360-$)
  • FDA/IoM "Uncertainty" Conference Adds Uncertainty to Biogen Growth Plans ForTysabri (RPM Report-$)
  • Regulatory Pathway for Achaogen Looks Better; Is It Aimed At Viable Commercial Market? (RPM Report-$)
  • Endocrinologic and Metabolic Drugs Advisory Committee; Notice of Meeting (FDA)
  • Blood Products Advisory Committee; Notice of Meeting (FDA)
  • Med-Vet International Issues Nationwide Recall of Veterinary 1/2cc U-40 Insulin Syringes Due to Mismarked Syringe Barrels (FDA)

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

  • FDA Fast Tracks Egalet Pain Drugs (Press)
  • Tesaro On Track For Mid-Year NDA Filing Of Oral CINV Candidate Rolapitant (Pink Sheet-$)
  • SCYNEXIS Receives Qualified Infectious Disease Product (QIDP) Designation from the FDA for Antifungal Agent SCY-078 for Oral Use (Press)
  • Merck's 9-valent HPV vaccine V503 under FDA review (SCRIP-$) (MM&M) (Fierce) (BioCentury)

US: Pharmaceuticals and Biotechnology: General

  • Comparing Economic Impact Estimates of "Reverse Payment" Settlements (Matrix Global Advisors)
  • Why is Forest Laboratories discontinuing Namenda? (GeriPal)
  • Pfizer, MIT will work together to improve biologic drug manufacturing (BioFlash)
  • GlaxoSmithKline lobbies for restrictions on e-cigs, which compete with its nicotine products (Fierce)
  • Dutch life science startup offers access to late-stage drugs for patients with few options (MedCity News)
  • Gilead's Hepatitis C Pill Takes Off Like A Rocket (Forbes)
  • Is Medicare drug coverage in jeopardy? (The Hill)

US: Medical Devices

  • WSJ Attack on Sham Surgery Is About Healthy Profits, Not Patients (Forbes)
  • BioMérieux's BioFire sets course for GI panel FDA clearance (Fierce)
  • Endo Puts Aside $520M For Vaginal Mesh Litigation (Law 360-$)
  • Report: FDA panel recommends Inspire Medical's sleep apnea implant (Mass Device)
  • Class 1 Device Recall for Merit Medical's Custom Procedural Trays (FDA)
  • Marvao Medical Receives second FDA Clearance for its NexSite™ HD Catheter product line (Press)
  • BioElectronics Applauds FDA Recommendation to Reclassify Shortwave Medical Devices to Class II (Press)

US: Dietary Supplements

  • 'Borrowed' science, patent infringements, and 'follow-on' NDI's: Sabinsa takes a stand on IP (Nutra Ingredients)

US: Assorted And Government

  • Enforcement Report - Week of February 19, 2014 (FDA)

Upcoming Meetings And Events

  • Other Upcoming FDA Advisory Committee Meetings And Topics (FDA)

Europe

  • CHMP Approves Ten New Medicines for Approval (EMA) (Teva) (GSK) (Reuters) (SCRIP-$) (Bloomberg)
  • Another Breast Implant Recall in France, Australia (TGA)
  • European Medicines Agency gives second positive opinion for a paediatric-use marketing authorization (EMA)
  • European Medicines Agency recommends restricting the use of methysergide-containing medicines (EMA)
  • European Medicines Agency recommends that Protelos/Osseor remain available but with further restrictions (EMA)
  • European Medicines Agency recommends restricting the use of methysergide-containing medicines (EMA)
  • European Medicines Agency advises on compassionate use of a new combination therapy for chronic hepatitis C (EMA)
  • Spanish Agency of Medicines and Medical Devices Agency Issues EudraGMDP Letter against API Manufacturer (EudraGDMP)
  • Companies hit by PMCPA for sponsored 'weekend family gathering' (Pharmafile)
  • German drug legislation moving forward (BioCentury)

India

  • UL Allies With India Group To Teach U.S. FDA Compliance To Local Makers (PharmAsia-$)
  • Health Ministry asserts that no reports of rise in spurious drugs in India (PharmaBiz)

Other International

  • Australia to adopt EMA's monoclonal antibody guideline (GABI)
  • Excipient makers jump on audits as new regs kick in (Fierce)

General Regulatory And Interesting Articles

  • How Software Will Kill-or Save-Medical Devices (Qmed)
  • Guiding principles for biosimilars development (GABI)

Regulatory Reconnaissance #261 - 21 February 2014

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.

Did we miss a story? Send us a tweet at @RAPSorg and we'll check it out for inclusion in our next edition of Regulatory Reconnaissance. Want this in your inbox each morning? Sign up for RF Today, our morning intelligence newsletter here.

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


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