Regulatory Focus™ > News Articles > Regulatory Reconnaissance (29 August 2013)

Regulatory Reconnaissance (29 August 2013)

Posted 29 August 2013 | By Alexander Gaffney, RAC

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing. Tips? Gripes? Let me know: news@raps.org.

In Focus: US

  • US FDA Worried as California Passes Biosimilar Use Bill (Biopharma Reporter) (BioCentury)
  • FDA Gives Metabolism/Endocrinology Division An Acting Director (Pink Sheet)
  • Public Shaming: FDA Edges Closer to Citizen Petition Denial for Intent to Delay Generic Drug Approval, But Prefers to Pass the Buck on Enforcement (FDA Law Blog)
  • Pharmacylics' New Drug Application Filing for Ibrutinib Accepted in Two B-cell Malignancies by the U.S. FDA (Pharmacylics)
  • HHS Urged to Take Bigger Role in Trial Consent Process (MedPage Today)
  • Difficulty Identifying Experts Seen as a Factor in Poor Investigations (Gold Sheet)
  • Health lawyer: Feds must be more 'holistic' in HIT regulatory framework (Fierce)

In Focus: International

  • How the Rest of the World's Capacity-Building Impacts the Global Regulatory Dossier (Gold Sheet)
  • Health experts critical of pharma industry's new transparency rules (EurActiv)
  • Discord Remains On EU Clinical Trials Transparency, Even Within Industry (Pink Sheet) (SCRIP)
  • India confirms NIH trial cutback amid compensation concerns (SCRIP)
  • Some Indian Companies Reformulating Drugs to Beat Dept. of Pharmaceuticals' Price Controls (PharmaBiz)
  • How colour-changing technology could revolutionise the medical industry (The Guardian)

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

US

Pharmaceuticals/Biotechnology
  • US FDA Worried as California Passes Biosimilar Use Bill (Biopharma Reporter) (BioCentury)
  • FDA Gives Metabolism/Endocrinology Division An Acting Director (Pink Sheet)
  • Public Shaming: FDA Edges Closer to Citizen Petition Denial for Intent to Delay Generic Drug Approval, But Prefers to Pass the Buck on Enforcement (FDA Law Blog)
  • Pharmacylics' New Drug Application Filing for Ibrutinib Accepted in Two B-cell Malignancies by the U.S. FDA (Pharmacylics)
  • Groups Push Modified FDASIA Reqs, Exemption For Drug Excipient Importers (IHP)
  • Swiss drugmaker Novartis recalls 4.4 million bottles of Maalox (Fierce)
  • CROs Could See Uptick in Pediatric Trials as FDA Begins Crackdown (Outsourcing Pharma)
  • BIO Comments on new FDA Final Guidance on IRBs (BIO)
  • FDA Approves Mylan's Generic Focalin (Dexmethylphenidate HCL, ANDA #202580) (FDA)
  • Idaho AG wraps up six years of litigation against drugmakers that recovered $28.4M (MedCity News)
  • Actavis Files FDA Application for Generic Rayos (PharmPro)
  • New Entrant in Obesity Drug Race Targets Body, Not the Mind (Reuters)
  • Astex reports positive PhII results for leukemia drug (Fierce) (BioCentury) (SCRIP)
  • PhII suggests biomarker-indication for Roche advanced AMD drug (SCRIP)
  • Public Citizen Wants HHS To Stop Trials Over Consent Issue (Law 360)
  • New Actelion Drug Found Safe And Effective In Pulmonary Arterial Hypertension-- But Does It Save Lives? (Forbes)
  • Alimera, pSivida Eye Drug Warrants FDA Approval On Third Try (The Street)
  • QRxPharma tumbles on 2nd FDA rejection for pain drug MoxDuo (SCRIP)
  • FDA reviewing sNDA for Boehringer's Pradaxa (BioCentury) (SCRIP)
  • Horizon Pharma Targets Actavis Over Generic Rayos (Law 360)
  • AHA.13 offers 20 late-breaking trials (Cardiovascular Business)
Pharmaceuticals: General
  • White House pushes anti-overdose drug (The Hill)
  • Groups Press for Passage of Pennsylvania Vaccination Bill (DSN)
Medical Devices
  • Health lawyer: Feds must be more 'holistic' in HIT regulatory framework (Fierce)
  • Spinal Modulation launches pivotal trial for neurostim device (Fierce)
  • FDA clears Dallen Medical's compression for sternal closure (Mass Device)
  • Blue Shield of California to curb coverage of pricey cancer therapy (LA Times)
Assorted And Government
  • HHS Urged to Take Bigger Role in Trial Consent Process (MedPage Today)
  • Difficulty Identifying Experts Seen as a Factor in Poor Investigations (Gold Sheet)
  • Contract Manufacturing Draft Guidance Overly Prescriptive, Out Of Touch - OTC Industry (Pink Sheet)
  • Natural Products Insider Launches Warning Letter Tracker for Dietary Supplements (NPI)
  • Enforcement Report - Week of August 28, 2013 (FDA)
  • FDA Scientists Showcase Cutting-Edge Research (FDA)
  • Taking an enterprise view on serialization (Pharma Commerce)
  • California's Lawyers Begin to Target Health Claims, Labels of Food Products (Bloomberg)
  • In Congress, a Bid to Undo Dialysis Cuts (NYTimes)
  • Think twice before asserting a trade secrets claim (Inside Counsel)
  • New scoring system will use EHR data to reduce adverse drug events (Fierce)
Upcoming Meetings And Events
  • 26 August 2013: WMA Declaration of Helsinki Meeting (WMA)
  • 4-5 September 2013: Public Workshop on the Trial Designs and Endpoints for Liver Disease Secondary to Nonalcoholic Fatty Liver Disease (FDA)
  • 24 September 2013: Public Meeting on Narcolepsy Patient-Focused Drug Development (FDA)
  • 25-26 September 2013: FDA Small Business Regulatory Education for Industry Conference (FDA)
  • Other Upcoming FDA Advisory Committee Meetings And Topics (FDA)

Europe

  • Health experts critical of pharma industry's new transparency rules (EurActiv)
  • Discord Remains On EU Clinical Trials Transparency, Even Within Industry (Pink Sheet) (SCRIP)
  • Bayer Receives Approval for Eylea in Next Indication in Europe (Bayer)
  • As Annex 16 Revision Proceeds, QPs Urged to Focus on Quality Systems in Certifying Batches (Gold Sheet)
  • Epirus reports Phase III RA data for Remicade biosimilar, plans Q4 filing (BioCentury) (Pharma Letter)
  • St. Jude Medical Receives European Approval for New Renal Denervation System That Reduces Total Ablation Time by More Than 80 Percent (St. Jude)
  • MHRA Issues Device Alerts for Medtronic, BD Devices (MHRA) (MHRA)
  • Germany publishes rare diseases action plan (BioCentury)
  • EFPIA Statement on Compulsory Licensing and Access to Medicines (EFPIA)
  • The European Pharmacopoeia Commission adopts two new BRPs (EDQM)

Asia

  • India confirms NIH trial cutback amid compensation concerns (SCRIP)
  • Some Indian Companies Reformulating Drugs to Beat Dept. of Pharmaceuticals' Price Controls (PharmaBiz)
  • Indian official disputes Novartis chief's patent complaints (Fierce) (India Times)
  • Japan's MHLW, MEXT Approve Interim Report For Ethical Clinical Research Guidelines (PharmAsia)
  • India: Number of spurious drugs comes down significantly during 2012-13 (PharmaBiz)
  • J&J rejigs Chinese ops to centralize under local chairman (Fierce)

Other International

  • How the Rest of the World's Capacity-Building Impacts the Global Regulatory Dossier (Gold Sheet)
  • Health Canada Releases Guidance on Natural Health Products for Consultation (HC)

General Regulatory And Interesting Articles

  • How colour-changing technology could revolutionise the medical industry (The Guardian)
  • Health from above: a drone to deliver defibrillators to heart attack victims (The Verge)
  • Hold onto your hats, pharma: Scientists grow 3-D mini-brains successfully (MedCity News)
  • Scientists figure out how to make one brain control two bodies (MedCity News)
  • Don't Be Scared If Your Surgeon Is Wearing Google Glass In The Operating Room (Fast Co-Exist)
  • A Mathematical Model of How to Tackle the Vicodin Abuse Problem (MIT Tech Review)
  • Taking into account alternative symptoms, men and women have similar rates of depression (Reuters)
  • BRCA1 mutation not linked to worse cancer survival (Reuters)
  • Psych Drugs Don't Raise Death Risk in Mental Illness (MedPage Today)
  • Prescription-Drug Coupons - No Such Thing as a Free Lunch (NEJM)

Regulatory Reconnaissance #142  - 29 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