Regulatory Focus™ > News Articles > Regulatory Reconnaissance (8 August 2013)

Regulatory Reconnaissance (8 August 2013)

Posted 08 August 2013 | By Alexander Gaffney, RAC 

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

In Focus: US

  • Former OGD Director: Generic Drugmakers Are Grumbling About The FDA (Pharmalot)
  • The Uncertain Future Facing Generic Drugmakers (Forbes) (Pharmalot)
  • Counterfeit Drugs in Clinical Trials? (Placebo Control)
  • The FDA and Killer Tylenol. Are They Kidding? (Medical Progress Today)
  • FDA 483s: 3 Tips for Inspection Day (FDAzilla)
  • FDA Reviews Accuracy Of 510(k) 'Refuse To Accept' Decisions (IHP)
  • Mixed Reaction to FDA Approval of ADHD Brain-Wave Test (Medscape)
  • NIH, Lacks family reach understanding to share genomic data of HeLa cells (NIH) (SCRIP) (Reuters) (NPR) (BIoCentury)
  • Monetization: An Impediment to Clear Thinking About the Merits of FDA Regulations? (FDA Law Blog)

In Focus: International

  • Orexigen Plans to File MAA in EU After US Setbacks (Pharma Letter)
  • Cyberdyne HAL Robosuit Cleared in Europe for Lower Body Rehab (MedGadget) (Mass Device)
  • EC approves Bavarian Nordic's smallpox vaccine (BioCentury)
  • EC Approves Velcade as a Frontline Induction Therapy before Stem Cell Transplantation (Janssen)
  • India's DCGI keen to strengthen regulatory mechanism for medical device sector (PharmaBiz)
  • Second Japan Diovan study found compromised (SCRIP)
  • Japan Health Authorities Mull Five-Year Clinical Research Retention Rule (PharmAsia)
  • MHLW Japan: Reports Of Side Effects Have Increased As Reporting System Is More Frequently Used (PharmAsia)
  • South Africa Urged To Overhaul Patent Laws To Boost Access To Meds (Pharmalot)
  • Expiring Drugs with Expiring Labels (MedGadget)

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

US

Pharmaceuticals/Biotechnology
  • Former OGD Director: Generic Drugmakers Are Grumbling About The FDA (Pharmalot)
  • The Uncertain Future Facing Generic Drugmakers (Forbes) (Pharmalot)
  • Counterfeit Drugs in Clinical Trials? (Placebo Control)
  • FDA denies breakthrough for Ariad's AP26113 (BioCentury)
  • The FDA and Killer Tylenol. Are They Kidding? (Medical Progress Today)
  • On Access and Accountability - Two Supreme Court Rulings on Generic Drugs (NEJM)
  • FDA 483s: 3 Tips for Inspection Day (FDAzilla)
  • Buprenorphine Decision Spurs Further Call For Shared REMS Rulemaking (IHP)
  • After escape from Lilly's graveyard, Type 1 diabetes drug promising in trial (Fierce)
  • Pfizer to Pay $1.8 Million in Prempro Punitive Damages (Bloomberg)
  • FDA Approves Hanmi's NDA for Nexium (Esomeprazole Strontium) (#202342) (FDA)
  • Trends in Drug Approvals: 1987-2011 (Healthcare Economist)
  • Senate Cites GAO Report on Compounding to Spur Action on Legislation (Senate)
  • Anesthesia: Is it Safe for Young Brains? (FDA)
  • Health insurer clarifies compounded drug policy (Boston Herald)
  • FDA Grants Orphan Drug Status To Eisai's Investigational Compound (E7777) For Cutaneous T-Cell Lymphoma (Eisai)
  • Novartis says Afinitor fails liver cancer trial (PMLive) (SCRIP) (Pharma Letter) (Pink Sheet) (BioCentury)
  • India-made prostate cancer drug files for IND with FDA (BioSpectrum) (India Times)
  • Jubilant Biosys Announces Successful Filing of Investigational New Drug with US-based Endo Pharmaceuticals (Jubilant)
Pharmaceuticals: General
  • Teva Announces Over-The-Counter Availability of Plan B One-Step (levonorgestrel) tablet 1.5 mg for All Consumers (Teva) (DSN)
Medical Devices
  • FDA Reviews Accuracy Of 510(k) 'Refuse To Accept' Decisions (IHP)
  • Mixed Reaction to FDA Approval of ADHD Brain-Wave Test (Medscape)
  • Class 1 Recall for CareFusion's ALaris PC Unit for Improper Voltage (FDA) (Fierce) (FDA)
  • Class 1 Recall for Cordis' OptEase Vena Cava Filter (FDA)
  • RestoreSensor SureScan MRI Neurostimulator FDA Approved for Full Body MRI (MedGadget) (MedCity News)
  • FDA clears Verizon Wireless home health app as Class II medical device (MobiHealth News)
Assorted And Government
  • NIH, Lacks family reach understanding to share genomic data of HeLa cells (NIH) (SCRIP) (Reuters) (NPR) (BIoCentury)
  • Monetization: An Impediment to Clear Thinking About the Merits of FDA Regulations? (FDA Law Blog)
  • Park Doctrine: Unknowing company executives can be held responsible for regulatory violations (Inside Counsel)
  • DMAA Cleared in Army Deaths, Still Poses Risks (Natural Products Insider) (Nutra Ingredients)
  • Best Way to Kill Lab Animals Sought (Scientific American)
  • Walgreen Can't Duck Supplement False Ad Suit (Law 360)
  • Probiotics Fail to Foil Diarrhea in Setback for Gut-Taming Pills (Bloomberg)
  • H.R.2960 -- Medicare Prescription Drug Integrity Act of 2013 (House)
  • Physician Payment Sunshine Act: Pfizer Grants Opts for Supporting Only Programs Accredited by the Five Bodies and No Meals (Policy and Medicine)
  • Enforcement Report - Week of August 7, 2013 (FDA)
  • ObamaCare cost-cutting board IPAB faces growing opposition from Democrats (The Hill)
  • How the Orphan Drug Tax Credit Leverages MDA's Fight against Rare Genetic Diseases (BIO)
  • Health and Beyond LLC Issues Voluntary Nationwide Recall of Tranquility Product Due to Product Having Traces of Pharmaceutical Ingredients (FDA)
  • 'Paying Till It Hurts': Why American Health Care Is So Pricey (NPR)
  • National Pharmaceutical Council Celebrates 60 Years (NPC)
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

  • Orexigen Plans to File MAA in EU After US Setbacks (Pharma Letter)
  • Cyberdyne HAL Robosuit Cleared in Europe for Lower Body Rehab (MedGadget) (Mass Device)
  • EC approves Bavarian Nordic's smallpox vaccine (BioCentury)
  • BI backs transparency but calls for IP protection (Pharma Times)
  • European Commission Approves Velcade as a Frontline Induction Therapy before Stem Cell Transplantation (Janssen)
  •  GSK Submits Regulatory Application for Cervarix in the EU (GSK)
  • GSK submits Votrient for ovarian cancer in Europe (PMLive)
  • Pay-for-delay fine widens Lundbeck loss (Pharma Times)

Asia

  • India's DCGI keen to strengthen regulatory mechanism for medical device sector (PharmaBiz)
  • Second Japan Diovan study found compromised (SCRIP)
  • Japan Health Authorities Mull Five-Year Clinical Research Retention Rule (PharmAsia)
  • Japan's First Committee On Drugs Approves Three New Drugs Including J&J Schizophrenia Drug (PharmAsia)
  • MHLW Japan: Reports Of Side Effects Have Increased As Reporting System Is More Frequently Used (PharmAsia)
  • Indian top court to review drug pricing policy  (BioSpectrum)
  • India Mulls 30-Day Extension For Compliance With New Price Caps (PharmAsia)
  • Indian Pharma companies may get more time to re-label drugs (India Times)
  • Chinese Whistle-Blower Alleges Sanofi Bribed Doctors, Herald Says (Bloomberg)
  • China fines six companies for price fixing: Xinhua (Reuters)

Other International

  • South Africa Urged To Overhaul Patent Laws To Boost Access To Meds (Pharmalot)
  • Australian requirements and recommendations for pharmacovigilance responsibilities of sponsors of medicines (TGA)
  • Cytori's Celution® System Approved in Australia for Processing and Delivering Adipose-Derived Regenerative Cells (Cytori)

General Regulatory And Interesting Articles

  • Expiring Drugs with Expiring Labels (MedGadget)
  • Scientists seek to mutate H7N9, as 1st human transmission evidence emerges (SCRIP)
  • "The human body is an assembly of chemicals, as is all food and all medicine. So what we label as a drug is a social construct." - Neil deGrasse Tyson

Regulatory Reconnaissance #127  - 8 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