Regulatory Focus™ > News Articles > Regulatory Reconnaissance (25 April 2013)

Regulatory Reconnaissance (25 April 2013)

Posted 25 April 2013 | By Alexander Gaffney, RAC 

Good morning and welcome to another edition of Regulatory Reconnaissance.

In Focus: US

  • AstraZeneca gets US Subpoena Over UK Drug Factory (Reuters)
  • FDA Designates Merck's Lambrolizumab as a Breakthrough Product (Merck) (Reuters) (DDDMag) (Fierce Biotech)
  • FDA Discouraging Real-Time Release Testing as a Shortcut to End Testing, Experts Say (Outsourcing Pharma)
  • White House Releases New Drug Control Policy (White House) (The Hill) (FDA)
  • FDA Surveillance App Could Actually Help Device Makers In Court (Law 360) ($)
  • FDA Calls for Comments on Clinical Research Protections, IRBs and Informed Consent Procedures (FDA)

In Focus: International

  • ENVI Committee Meets to Discuss Medical Device Overhaul Proposals (ENVI)
  • Australia Recognized by the EU as Meeting API Requirements (EurLex)
  • UK Panel Calls for National Breast Implant Registry (Fierce Medical Devices)
  • Maker of faulty French Breast Implants Apologizes (Reuters)
  • OTC Oxytrol Approval In U.S. Highlights European Switch Struggles (The Pink Sheet) ($)

Comments? Suggestions? Shoot me an email at news@raps.org.

US

Pharmaceuticals/Biotechnology
  • AstraZeneca gets U.S. subpoena over UK drug factory (Reuters)
  • FDA Designates Merck's Lambrolizumab as a Breakthrough Product (Merck) (Reuters) (DDDMag) (Fierce Biotech)
  • FDA Discouraging Real-Time Release Testing as a Shortcut to End Testing, Experts Say (Outsourcing Pharma)
  • Psoriasis Drug Like Biogen's BG-12 Linked to Brain Disease (Bloomberg) (Pharmalot)
  • White House Releases New Drug Control Policy (White House) (The Hill) (FDA)
  • Drugmakers Must 'Show Up' to Learn Supplier Changes (FDA News) ($)
  • Ipsen expects Increlex supply interruption due to supplier manufacturing issues (Ipsen)
  • Astellas Sued Over Delays of Prograf Generic (Law 360) ($)
  • Kroger Pharmacy Expansion Is Contaminated By A Compounder (Forbes)
  • Abbott's Humira Caused Serious Fungal Infection, Jury Hears (Law 360) ($)
  • CDER's Janet Woodcock: Nobody Can Really Tell Me If FDA Inspections Are Effective (Pharmaceutical Online)
  • Eisai to deploy GE's Alzheimer's imaging agent for clinical trial screening (Fierce Medical Devices)
  • With Supreme Court weighing a case, GSK's Andrew Witty says 'pay-to-delay' label misleading, defends such settlements (Philly Pharma)
  • Industry Weighs in of FDA Draft Guidance on Immunogenicity Assessment for Therapeutic Protein Products (FDA Docket)
  • Cydan, the NEA Startup Machine, Scours the Globe for Orphan Drugs (Xconomy)
  • Achaogen Lands $60 Million Biomedical Advanced Research and Development Authority (BARDA) Contract (BioSpace)
  • Once-daily AUBAGIO Delayed Onset of Clinically Definite Multiple Sclerosis (MS) in TOPIC Study (Sanofi)
  • Lilly submitting ramucirumab BLA (BioCentury)
  • Teva pain treatment gets FDA orphan drug status (Med City News)
  • FDA Approves Manufacturing Changes for Cephalon's Actiq, Daiichi Sanyo's Welchol, and Bracco's Cardiogen-82 (FDA)
Medical Devices
  • Recall costs wipe out Stryker's profit (Fierce Medical Devices) (MDDI)
  • FDA Surveillance App Could Actually Help Device Makers In Court (Law 360) ($)
  • J&J's glucose meter recall gets FDA's most serious tag (Fierce Medical Devices) (FDA) (FDA)
  • Orthopaedic and Rehabilitation Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting (FDA)
  • Vascular Solutions can't dodge illegal marketing lawsuit (Mass Device)
  • Class 1 Recall for Engineered Medical Systems' SealFlex Single Port Ribbed Mask for Infants (FDA)
  • Class 1 Recall for GE Healthcare's Giraffe OmniBed and Giraffe Incubator (FDA) (FDA) (Mass Device)
  • The Future of Mobile Technology in Medicine: Innovative Medical Apps (Med City News)
  • FDA Calls for Comments on IDE Reports and Records (FDA)
Assorted
  • FDA Calls for Comments on Clinical Research Protections, IRBs and Informed Consent Procedures (FDA)
  •  Coalition: Educational Materials Should Be Excluded from Sunshine Reporting (Coalition for Healthcare Communication)
  • Patient-Centered Outcomes Research Institute Names Bryan Luce Chief Science Officer (PCORI)
  • FDA's MedWatch Safety Alerts: March 2013 (FDA)
  • Enforcement Report - Week of April 24, 2013 (FDA)
  • Sen. Martin Heinrich: 'The model that DSHEA created is working well' (Nutra Ingredients USA)
  • No Monkeying Around: Harvard Closing Primate Research Center (Pharmalot)
  • Trying to Burnish Its Image, J.&J. Turns to Emotions (NYTimes)
  • Scorecard Shows U.S. Medical Schools Continue to Make Progress in Pharmaceutical Conflict-of-Interest Policies (Postscript)
Warning Letters
  • (Medical Device) CORPAK MedSystems for CAPA, CGMP, Adverse Event Reporting (FDA)
  • (Pharmaceutical) Birkdale Medicinals for Marketing, Misbranding, New Drug (FDA)
  • (Blood Product) Puget Sound Blood Center for Quality Problems (FDA)
Government and Budget
Upcoming Meetings and Events
  • 22 April 2013: Public Meeting - International Consortium of Cardiovascular Registries (FDA)
  • 23 April 2013: FDA Webinar: Home Use of Diabetes and Cardiovascular Medical Devices (FDA)
  • 23 April 2013: Margaret Hamburg to Keynote FDLI's Conference (FDLI) (Speech)
  • 23 April 2013: FDA Listening Meeting on Use of Antibiotics in Animals in Olympia, WA (FDA)
  • 25 April 2013: Securing Our Nation's Prescription Drug Supply Chain (Energy and Commerce Committee)
  • 25-26 April 2013: Clinical Chemistry and Clinical Toxicology Devices Panel of the Medical Devices Advisory Committee Meeting (FDA) (Meeting Materials Posted)
  • 25-26 April 2013: Drug Development for Myalgic Encephalomyelitis and Chronic Fatigue Syndrome (ME and CFS) (FDA)
  • 26 April 2013: Senate Appropriations Committee to Markup FDA Bill (Appropriations)
  • 26 April 2013: Does HIPAA Help or Hinder Patient Care and Public Safety? (Energy and Commerce Committee)
  • Other Upcoming FDA Advisory Committee Meetings and Topics (Eye on FDA) (FDA)

International

  • ENVI Committee Meets to Discuss Medical Device Overhaul Proposals (ENVI)
  • Australia Recognized by the EU as Meeting API Requirements (EurLex)
  • Panacea Biotec accused of selling expired vaccines (Fierce Vaccines)
  • Maker of faulty French breast implants apologizes (Reuters)
  • Health ministry's whistle-blower scheme to trace spurious drugs fails as no case reported in 4 years (PharmaBiz)
  • A Canadian Drug Safety Boondoggle: Cassels Explains (Pharmalot)
  • WHO launches emergency response to antimalarial drug resistance (WHO)
  • Scotland launching center for trial stratification (BioCentury)
  • U.K. panel calls for national breast implant registry (Fierce Medical Devices)
  • OTC Oxytrol Approval In U.S. Highlights European Switch Struggles (The Pink Sheet) ($)
  • India Ministry Says Only 17 Of 2,644 Trial Deaths Past Seven Years Related (PharmAsia News) ($)
  • Janssen Submits Marketing Authorisation Application for Simeprevir (TMC435) to the European Medicines Agency for the Treatment of Adult Patients with Chronic Hepatitis C Genotype 1 or Genotype 4 (J&J)
  • UK Announces Recall of Diazepam Tablets (MHRA)

General Regulatory and Interesting Articles

  • What If They Treated Gene Patents Like Nautical Charts? (Forbes)
  • No link between vaccines and Guillain-Barré in big study (Fierce Vaccines)
  • A Tale Of Mice And Medical Research, Wiped Out By A Superstorm (NPR)
  • Bird Flu Seen Beyond Mainland, in Taiwan (WSJ)
  • New $5.5 billion plan aims to rid world of polio by 2018 (Reuters)
  • A Biomarker for Autism? (NYTimes)
  • Protect Yourself from a Hack Attack (BIO)

Regulatory Reconnaissance #53 - 25 April 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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