Regulatory Focus™ > News Articles > Regulatory Reconnaissance (5 August 2013)

Regulatory Reconnaissance (5 August 2013)

Posted 05 August 2013 | By Alexander Gaffney, RAC

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

In Focus: US

  • Can FDA Lawfully Overrule SCOTUS Generic Drug Preemption Decision Through Regulation? (Forbes)
  • J&J Unit Gets U.S. OIG Subpoena Regarding Painkiller Nucynta (WSJ) (SCRIP)
  • FDA reviewers recommend approval of Bayer hypertension drug (Reuters) (Pink Sheet) (Fierce) (Pharma Times) (BioCentury) (SCRIP) (Pharma Times)
  • Forest's Fetzima Will Test Enantiomer Exclusivity Policy Change (Pink Sheet)
  • FDA Officials Weigh in on Special Medical Use Pathway (Drug Wonks)
  • FDA Reviewers Pan Otsuka's Tolvaptan Trial Results (MedPage Today) (SCRIP)
  • Public Citizen Issues Public Warning Against Use of New Partial-OTC Switch Drug Oxytrol (Public Citizen) (Report)
  • FDA Workshop Shines Spotlight On Device Battery Hazards And Potential Solutions (Gray Sheet)
  • In Need of a New Hip, but Priced Out of the U.S. (and Regulation is a Factor) (NYTimes)
  • Congress Adjourns for August Recess, Leaving Fate of FDA's Budget Uncertain (Strengthen FDA)

In Focus: International

  • EMA publishes guidance on validation process for initial marketing authorization (EMA) (EMA)
  • EMD Millipore says Formal Excipient GMP would Level Playing Field (In-Pharma)
  • Making sense of medicine information leaflets in the EU (MNT)
  • India partly revokes Roche cancer drug patent (Reuters) (India Times) (BioCentury) (PMLive)
  • Daiichi Sankyo attempts to restore Ranbaxy's credibility, but difficult road ahead (Economic Times)
  • India's Supreme Court Calls on Regulators to Discuss Clinical Trials Further (Outsourcing Pharma)

Comments? Suggestions? Email me at news@raps.org.

US

Pharmaceuticals/Biotechnology
  • Can FDA Lawfully Overrule SCOTUS Generic Drug Preemption Decision Through Regulation? (Forbes)
  • J&J Unit Gets U.S. OIG Subpoena Regarding Painkiller Nucynta (WSJ) (SCRIP)
  • FDA reviewers recommend approval of Bayer hypertension drug (Reuters) (Pink Sheet) (Fierce) (Pharma Times) (BioCentury) (SCRIP) (Pharma Times)
  • Forest's Fetzima Will Test Enantiomer Exclusivity Policy Change (Pink Sheet)
  • FDA Officials Weigh in on Special Medical Use Pathway (Drug Wonks)
  • FDA Reviewers Pan Otsuka's Tolvaptan Trial Results (MedPage Today) (SCRIP)
  • Public Citizen Issues Public Warning Against Use of New Partial-OTC Switch Drug Oxytrol (Public Citizen) (Report)
  • FDA Extends PDUFA Date for GSK's Albiglutide by Three Months (GSK) (Reuters) (Fierce) (BioCentury) (SCRIP) (Pharma Letter) (PMLive)
  • FDA User Fees In FY 2014: Burden Per Application Grows As Submission Projections Fall (Pink Sheet)
  • GSK's Anoro Ellipta Heads To FDA Panel With Higher Hopes For Higher Dose (Pink Sheet)
  • High Court's Sorrell Ruling Yet To Transform Drug Marketing (Law 360)
  • Benztropine Mesylate Injection (Nexus Pharmaceuticals): Recall - Visible Particulate Matter (FDA)
  • Determination That CYTOXAN (Cyclophosphamide) for Injection Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness (FDA)
  • Nasacort AQ Switch Gets NDAC Nod Despite Pediatric Use Concerns (Pink Sheet)
  • Updated Compounding Bill Exempts Infusion Pharmacies (IHP)
  • Rep. Spencer Bachus Calls on FDA to Approve Eteplirsen (Scout)
  • Regulators clear incretin mimetics - for now (EP Vantage)
  • Drugmaker UCB Sues Rival Sun Over Planned Vimpat Generic (Law 360)
  • Fee Schedule for Reference Biological Standards and Biological Preparations (CDC)
  • FDA allows meningitis vaccine for infants as young as 2 months (DSN)
  • FDA Approves Hikma's Generic Amaryl (Glimepiride, #078952), Novast Labs' Generic Mircette/Desogen (Desogestrel; Ethinyl Estradiol; Ethinyl Estradiol, #091247), and Haupt's Generic Norethindrone (#202260) (FDA)
  • Senate puts off vote for track-and-trace, compounding bill (DSN) (Securing Industry)
  • Sanofi starts late-stage test for Clostridium vaccine (Reuters)
  • Isis to stop developing rheumatoid arthritis drug (Reuters) (Fierce)
  • Synergy Pharmaceuticals Announces Positive End-of-Phase 2 Meeting with FDA for Plecanatide in Chronic Idiopathic Constipation (Synergy)
Pharmaceuticals: General
  • Plan B Finally Hit Pharmacy Shelves This Week (Think Progress)
  • Biosimilars Wedge Issue: Actavis Splits With GPhA In Supporting Calif. Notification Bill (Pink Sheet)
  • Sunshine In Your Pocket: Mobile Apps Help Docs Track Drug Firm Payments (Pink Sheet)
Medical Devices
  • FDA Workshop Shines Spotlight On Device Battery Hazards And Potential Solutions (Gray Sheet)
  • In Need of a New Hip, but Priced Out of the U.S. (and Regulation is a Factor) (NYTimes)
  • Bipartisan Committee Leadership Requests GAO Study of BioWatch (House)
  • Class 1 Recall: MRidium 1145 Dose Reduction System (DERS) (FDA)
  • Class 1 Recall: Alaris PC unit, model 8015 (FDA)
  • Boston-based company gets FDA clearance for noninvasive monitor aimed to help trauma-care clinicians treat patients in shock (MedCity News)
  • Gore & Associates Wins Patent Case Against St. Jude Subsidiary (Gore)
Assorted And Government
  • Senate joins effort to save FDA user fees from sequester (Fierce)
  • Lawmakers Press Administration For Answers On Sequestered FDA Fees (IHP)
  • SCRIP's US Capitol Capsule (SCRIP)
  • Congress Adjourns for August Recess, Leaving Fate of FDA's Budget Uncertain (Strengthen FDA)
  • Technology: Facebook, food and the FDA (Inside Counsel)
  • Sunshine On Journal Article Reprints Could See Legal Challenge (Pink Sheet)
  • House Passes REINS Act to Curb Regulation (House) (Law 360)
  • H.R.2869 -- Medicare Patient Access to Cancer Treatment Act of 2013 (House)
  • H.R.2853 -- Hospital Price Transparency and Disclosure Act of 2013 (House)
Upcoming Meetings And Events
  • 5 August 2013: Webinar: Draft GFI On Expedited Programs For Serious Conditions Drugs And Biologics (FDA)
  • 5 August 2013: Cardiovascular and Renal Drugs Advisory Committee Meeting (FDA)
  • 6 August 2013: Cardiovascular and Renal Drugs Advisory Committee Meeting (FDA)
  • 15 August 2013: Alliance for a Stronger FDA/FDA International Programs Meeting (Strengthen FDA)
  • Other Upcoming FDA Advisory Committee Meetings And Topics (FDA)

Europe

  • EMA publishes guidance on validation process for initial marketing authorization (EMA) (EMA)
  • EMD Millipore says Formal Excipient GMP would Level Playing Field (In-Pharma)
  • Making sense of medicine information leaflets in the EU (MNT)
  • MHRA Warns About Luer Adaptor Manufactured by BD (MHRA)
  • ThromboGenics/Alcon's Jetrea gets strongest AMNOG endorsement yet from German HTA (SCRIP)

Asia

  • India partly revokes Roche cancer drug patent (Reuters) (India Times) (BioCentury) (PMLive)
  • Daiichi Sankyo attempts to restore Ranbaxy's credibility, but difficult road ahead (Economic Times)
  • India's Supreme Court Calls on Regulators to Discuss Clinical Trials Further (Outsourcing Pharma)
  • Baxter Found Expense Violations in China (WSJ)
  • Indian ISCR expresses concern over steady drop in approvals for clinical trials (PharmaBiz)
  • PMDA Announces Pharmaceutical Regulatory Strategy Consultation Results (PharmAsia)
  • China Introduces Three Rounds Of Pro-Device Policies In FY13 (PharmAsia)
  • Monthly paliperidone among new Japan recommendations (SCRIP)

Other International

  • INVIMA expands list of medical devices requiring registration in Colombia (Mass Device)
  • New Zealand's designer drug law draws global interest (CBS)
  • Roche to provide cheap Valcyte to patent pool (Pharma Times) (Roche) (PMLive)

Regulatory Reconnaissance #124  - 5 August 2013

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.


Regulatory Focus newsletters

All the biggest regulatory news and happenings.

Subscribe