Regulatory Focus™ > News Articles > Regulatory Reconnaissance (16 August 2013)

Regulatory Reconnaissance (16 August 2013)

Posted 16 August 2013 | By Alexander Gaffney, RAC 

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing. Your editor is taking every Friday off in August for vacation, but is making sure to keep you up-to-date with Regulatory Reconnaissance.

In Focus: US

  • FDA China Inspection Expansion Stymied by Visa Holdup: Official (FDA News) (Pink Sheet) (IHP)
  • Speedy Drug Approvals Don't Impact Safety: Report (DD&D)
  • Deaths tied to recalled drugs from Texas compounder (Fierce)
  • FDA issues warning on risk for possibly permanent nerve damage from antibacterial fluoroquinolone (FDA) (MedPage Today)
  • Top 10 Pitfalls of a 510(k) Submission and How to Avoid Them (MDDI)
  • Understanding FDA's Interpretation of Medical Device Design Control (MDDI)
  • Medical device cybersecurity tools in the real world (Mass Device)
  • Jury rules against Bard in vaginal mesh case (Fierce) (Mass Device)
  • FDA approves St. Jude's ablation catheter for MediGuide platform (MedCity News) (Fierce) (St. Jude)
  • Scientifically Valid: Lab Testing a Major Focus for FDA (Natural Products Insider)
  • Increased Enforcement in China Could Result in Large Fines in US and UK (Policy and Medicine)

In Focus: International

  • China Life Sciences Regulatory Crackdown Spreads to Medical Device Sector (HIWW)
  • Proposed Bill for South Africa Health Products Regulatory Authority (Pharma Letter)
  • NICE says no to Xalkori; appeal is 'pointless' says Pfizer (SCRIP) (BioCentury) (PMLive) (MNT) (Pink Sheet)
  • European Medicines Agency publishes reflection paper on general issues for consideration regarding coated nanomedicines (EMA) (EMA)
  • Five Tips for Developing Orphan Products (Pharma Manufacturing)

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

US

Pharmaceuticals/Biotechnology
  • FDA China Inspection Expansion Stymied by Visa Holdup: Official (FDA News) (Pink Sheet) (IHP)
  • Speedy Drug Approvals Don't Impact Safety: Report (DD&D)
  • Deaths tied to recalled drugs from Texas compounder (Fierce)
  • Avoiding FDA 483s Strategy #3: Lock down validation controls (FDAzilla)
  • FDA requires label changes to warn of risk for possibly permanent nerve damage from antibacterial fluoroquinolone drugs taken by mouth or by injection (FDA) (MedPage Today)
  • Novo Nordisk Sues Amneal Over Vagifem Generic (Law 360)
  • FDA Contract: Pharmakokinetic Analysis of Toxicants in Non-Human Primates (FDA)
  • FDA Approves Caraco's generic Macrobid (Nitrofurantoin) (FDA)
  • Questions on MannKind's inhaled insulin PhIII data cloud Afrezza's future (Fierce)
  • Cowtipping? Tyson Foods Has A Beef With Merck Animal Health (Pharmalot)
Pharmaceuticals: General
  • Patient groups press HHS to revisit ACA drug coverage (BioCentury)
  • Florida Pain Victims Trapped by Prescription Crackdown (Bloomberg)
Medical Devices
  • Top 10 Pitfalls of a 510(k) Submission and How to Avoid Them (MDDI)
  • Understanding FDA's Interpretation of Medical Device Design Control (MDDI)
  • Medical device cybersecurity tools in the real world (Mass Device)
  • Jury rules against Bard in vaginal mesh case (Fierce) (Mass Device)
  • FDA approves St. Jude's ablation catheter for MediGuide platform (MedCity News) (Fierce) (St. Jude)
  • InSightec's surgery-free brain tech eases tremor in study (Fierce)
  • PAD: Medtronic files for FDA approval of drug-eluting balloon (Mass Device) (Fierce)
  • Integra Lifesciences gains after FDA OKs plant (Mass Device)
  • Ortho Kinematics Receives FDA 510(k) Clearance to Expand into Cervical Spine (Ortho)
  • FDA Approves Apheresis Platelet Claims for Immunetics' BacTx Rapid Test for Bacterial Contamination (Apheresis) (BioFlash)
Assorted And Government
  • Scientifically Valid: Lab Testing a Major Focus for FDA (Natural Products Insider)
  • Increased Enforcement in China Could Result in Large Fines in US and UK (Policy and Medicine)
  • FDA Contract: Social Media Monitoring Tool (FDA)
  • New Dietary Ingredients Revisited - Let's Not Forget There's a Law (FDA Law Blog)
  • NIH-funded 'systems biology' project aims to solve TB conundrum (SCRIP)
  • National Center for Advancing Translational Sciences; Notice of Meetings (NCATS)
  • Homeopathic Drugmaker Puts Up $1M To End False Ad Claims (Law 360)
Upcoming Meetings And Events
  • 15 August 2013: Alliance for a Stronger FDA/FDA International Programs Meeting (Strengthen FDA)
  • 16 August 2013: Risk Communication Advisory Committee (FDA)
  • 19 August 2013: FDA Basics Webinar: Biological Products, Part 2: Biosimilar Biological Products (FDA)
  • 26 August 2013: WMA Declaration of Helsinki Meeting (WMA)
  • Other Upcoming FDA Advisory Committee Meetings And Topics (FDA)

Europe

  • NICE says no to Xalkori; appeal is 'pointless' says Pfizer (SCRIP) (BioCentury) (PMLive) (MNT) (Pink Sheet)
  • European Medicines Agency publishes reflection paper on general issues for consideration regarding coated nanomedicines (EMA) (EMA)
  • Biotech threatened by UK drug pricing changes, says BIA (PMLive) (Pharma Times)
  • G-BA assesses Sanofi's Zaltrap (BioCentury)

Asia

  • China Life Sciences Regulatory Crackdown Spreads to Medical Device Sector (HIWW)
  • A Preemptive Strike? Roche Relinquishes Its Herceptin Patent In India (Pharmalot) (Drug Wonks)

Other International

  • Proposed Bill for South Africa Health Products Regulatory Authority (Pharma Letter)
  • Health Canada Summary Basis of Decision for Fibristal (HC)

General Regulatory And Interesting Articles

  • Five Tips for Developing Orphan Products (Pharma Manufacturing)
  • Pandemic immune response hints at potential universal flu vax (Fierce)
  • Big Pharma And Its Research Publications (In the Pipeline)
  • Diabetes: Do smartphones fit the bill for the next mobile artificial pancreas? (Mass Device)

Regulatory Reconnaissance #133  - 16 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.


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