Regulatory Focus™ > News Articles > Regulatory Reconnaissance (4 November 2013)

Regulatory Reconnaissance (4 November 2013)

Posted 04 November 2013 | By Alexander Gaffney, RAC 

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing. Read anything we might be interested in sharing? Let us know: news@raps.org.

In Focus: US

  • Study: Herbal Supplements Often Contain Incorrect Ingredients (NYTimes)
  • FDA Breakthrough Approval of Roche's Gazyva Breaks No Speed Barriers (Pink Sheet-$)
  • The Flaw That Must Be Addressed in H.R. 3204, The Drug Quality and Security Act (RxTrace)
  • FDA Enforcement Letters On Rx Drug Promotions Plummet In 2013 (Pink Sheet-$)
  • CMS Director To Diagnostics Industry: Prove Your Cancer Tests Work (Gray Sheet-$)
  • Insurer accuses Intuitive Surgical of hiding legal claims over da Vinci robot (Mass Device) (MedCity News)
  • Rep. Urges FDA to Stop Illegal NDI Copycats (NPI) (Nutra Ingredients)

In Focus: International

  • AdvaMed urges Indian Parliamentary Committee to consider its views on Medical Devices Bill (PharmaBiz)
  • Bristol-Myers files for Japanese approval of first all-oral, interferon/ribavirin-free hep C treatment (Pharma Letter-$) (Reuters) (Press) (Pharma Times)
  • Criminal Complaint Filed Against Japan Novartis Unit, Alleging False Ads (PharmAsia-$) (Pharmalot)

US: Pharmaceuticals/Biotechnology

  • Development Times, Clinical Testing, Postmarket Follow-up, and Safety Risks for the New Drugs Approved by the US Food and Drug Administration (JAMA)
  • FDA Breakthrough Approval of Roche's Gazyva Breaks No Speed Barriers (Pink Sheet-$)
  • The Flaw That Must Be Addressed in H.R. 3204, The Drug Quality and Security Act (RxTrace)
  • Most drugmakers agree serialisation 'takes 4-5 years' (Securing Industry)
  • FDA Enforcement Letters On Rx Drug Promotions Plummet In 2013 (Pink Sheet-$)
  • GDUFA Success Depends On Industry Changes As Much As Review Improvements, FDA Says (Pink Sheet-$)
  • Sens. Harkin, Reed, Alexander, Murray, and Roberts Applaud News of 500th Drug Labeled with Pediatric Information (Senate)
  • FDA Announces New Labeling for Potiga After Patients Experience Blue Skin Discoloration (FDA)
  • Doctors Fear Losing Leukemia Drug Deemed Risky (NYTimes)
  • Legal Experts Debate FDA Independence After Plan B Fallout (Tan Sheet-$)
  • FDA Likely To Allow Outcomes Studies Post-Approval For Fat Emulsion Drugs (Pink Sheet-$)
  • 3 Pitfalls Posed By Over-The-Counter Drug Recalls (Law 360-$)
  • DEA Places Tramadol into Schedule IV (DEA)
  • Cancer-Drug Discovery and Cardiovascular Surveillance (NEJM)
  • Janssen Persuades Advisory Committee That Simeprevir Doesn't Need Contraindication (Pink Sheet-$)
  • For Gilead's Sofosbuvir, Questions Remain About Breadth Of Indication (Pink Sheet-$)
  • AASLD meeting highlights: Gilead's sofosbuvir, Janssen's simeprevir and Boehringer's faldaprevir  (Pharma Times) (Pharma Letter-$) (SCRIP-$) (BI) (Gilead)
  • High cure rates seen with Merck oral hepatitis drugs: study (Reuters) (Press) (Fierce) (Fierce)
  • Mylan files for approval of generic gout drug (DSN)
  • Sunovion Announces Publication of Two Pivotal Studies Supporting FDA Approval of Latuda (lurasidone HCl) for Bipolar Depression (Press)
  • Otsuka Says Wockhardt's ANDA Infringes Abilify Patent (Law 360-$)
  • Ranbaxy sues Actavis in US to prevent sale of acne generic (India Times) (BioSpectrum)
  • Warner Chilcott Sues Mylan To Block Generic Lo Loestrin (Law 360-$)
  • FDA Says Invega (Paloperidone) Generics Can Proceed (FDA)

US: Pharmaceuticals and Biotechnology: General

  • Using Big Data For CER Will Be Harder Than Safety Studies - PCORI Investigator Platt (Pink Sheet-$)
  • Getting Results From Big Data Depends On Trust Between Stakeholders (Pink Sheet-$)
  • Branded Drugs Chalk Up a Win Under Health Law (WSJ-$)
  • New pill could solve the meth problem (CBS)
  • Cheap Drugs From Canada- Good Idea? (MedCity News) (PhRMA: No)

US: Medical Devices

  • The Device Submission eCopy Requirements (FDA Law Blog)
  • CMS Director To Diagnostics Industry: Prove Your Cancer Tests Work (Gray Sheet-$)
  • Insurer accuses Intuitive Surgical of hiding legal claims over da Vinci robot (Mass Device) (MedCity News)
  • Perrigo Initiates Nationwide Voluntary Product Recall of Acetaminophen Infant Suspension Liquid, 160 mg/5 mL, Due to a Potential Defect with the Co-packaged Oral Syringe (FDA) (FDA)
  • 3-D Printed Implants Hit The Market, Pave The Way For More Personalized Devices (Gray Sheet-$)
  • FDA Grants FzioMed an Independent Review of its Oxiplex Gel by the Medical Devices Dispute Resolution Panel (Press)
  • Novo Nordisk gains US FDA approval for FlexTouch insulin pens (Pharma Letter-$) (Press) (DSN)
  • Class 1 Recall for TorFlex Guiding Sheath (FDA)

US: Dietary Supplements

  • Study: Herbal Supplements Often Contain Incorrect Ingredients (NYTimes)
  • Rep. Urges FDA to Stop Illegal NDI Copycats (NPI) (Nutra Ingredients)
  • Supplement Firm Claims First Amendment Protection For Testimonials (Tan Sheet-$)
  • CRN asks FDA to remove "extra-statutory" restriction from medical foods guidance (Nutra Ingredients)

US: Assorted And Government

  • OMB Explains Sequestration of User Fees (OMB)
  • In Between the FDA and Pharma, People Wait for Treatments (Atlantic)
  • SCRIP Capitol Capsule (SCRIP-$)

Upcoming Meetings And Events

  • 4-5 November 2013: Pediatric Oncology Subcommittee of the Oncologic Drugs Advisory Committee Meeting (FDA) (Day 2)
  • 5 November 2013: Hamburg Attending Bloomberg Innovation Event (BGov)
  • 8 November 2013: Ear, Nose and Throat Devices Panel of the Medical Devices Advisory Committee Meeting (FDA)
  • 13 November 2013: Peripheral and Central Nervous System Drugs Advisory Committee Meeting (FDA)
  • 13 November 2013: Vaccines and Related Biological Products Advisory Committee Meeting (FDA)
  • 14 November 2013: Peripheral and Central Nervous System Drugs Advisory Committee Meeting (FDA)
  • 19 November 2013: Endocrinologic and Metabolic Drugs Advisory Committee Meeting (FDA)
  • 2-3 December 2013: AHWP/RAPS Joint Conference in Malasia (RAPS)
  • 9 December 2013: Joint Meeting of the Gastrointestinal Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee (FDA)
  • 11 December 2013: Meeting of the Endocrinologic and Metabolic Drugs Advisory Committee (FDA)
  • Other Upcoming FDA Advisory Committee Meetings And Topics (FDA)

Europe

  • Editor's Note: 1 November 2013 was a holiday (All Saints Day) for some of the EU, and EMA was closed.

Asia

  • India's Wockhardt Sees Profit Nosedive On The Weight Of Import Bans (PharmAsia-$)
  • Bristol-Myers files for Japanese approval of first all-oral, interferon/ribavirin-free hep C treatment (Pharma Letter-$) (Reuters) (Press) (Pharma Times)
  • Criminal Complaint Filed Against Japan Novartis Unit, Alleging False Ads (PharmAsia-$) (Pharmalot)
  • AdvaMed urges Indian Parliamentary Committee to consider its views on Medical Devices Bill (PharmaBiz)
  • Aricept filed for Lewy body dementia in Japan (SCRIP-$)

Regulatory Reconnaissance #194 - 4 November 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.


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