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

Regulatory Reconnaissance (29 April 2013)

Posted 29 April 2013 | By Alexander Gaffney, RAC 

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

In Focus: US

  • Sequester Will Hinder Drug, Device Reviews, FDA Head Says (Law 360) ($)
  • Device Adverse Event Reports Hit All-Time High (The Gray Sheet) ($)
  • Breakthrough Therapies: FDA Not Writing A Scientific Guidance - Yet (The Pink Sheet) ($)
  • Actavis Generic OxyContin To Launch In 2014 Under Patent Settlement (The Pink Sheet) ($) (Fierce Pharma) (DSN)
  • Fraudulent wrinkle-filler Botox found in the U.S. (Reuters) (FDA)

In Focus: International

  • Teva discovers sophisticated fakes of popular drug (Financial Times)
  • India Mulls Local Market Ban Of Drugs Banned In Any Of Six Major Markets (PharmAsia News) ($)
  • CHMP backs Xtandi, Erivedge, Nuedexta (BioCentury) (Roche) (Pharma Times)
  • India's CDSCO to Zonal Offices: Keep Records on Clinical Trials (CDSCO)
  • Two new cancer drugs recommended in Europe (PMLive)

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

US

Pharmaceuticals/Biotechnology
  • Fraudulent wrinkle-filler Botox found in the U.S. (Reuters) (FDA)
  • Actavis Generic OxyContin To Launch In 2014 Under Patent Settlement (The Pink Sheet) ($) (Fierce Pharma) (DSN)
  • Shunned Gilead/Bristol-Myers hep C combo may be too good for docs to ignore (Fierce Biotech)
  • Court Rules Against Takeda in Actos Diabetes Case (Takeda) (Law 360) (The Pharma Letter)
  • FDA Flubbed Approval Of Generic Cattle Med, Judge Says (Lawsuit) (Law 360) ($)
  • AstraZeneca Didn't Deserve Seroquel Extension, DC Circ. Says (Judgment) (Law 360) ($) (The Hill)
  • Breakthrough Therapies: FDA Not Writing A Scientific Guidance - Yet (The Pink Sheet) ($)
  • Recall: Sodium Chloride Injection 0.9 percent USP, 100 mL Flexible Containers by Hospira (Particulate Matter) (FDA) (FDA)
  • FDA Posts Huge Batch of New Compounding 483s (FDA)
  • FDA Approves Mallinckrodt's Oxymorphone Hydrochloride, Emsure Pharmaceuticals' Nefedipine, Lupin's Pirmella (ethinyl estradiol; norethindrone), and Amneal Pharmaceutical's Promethazine HCl and Codeine Phosphate (FDA)
  • Shareholders Criticize J&J for Mistakes (DDDMag)
  • CBER Approves LEUKOSEP HWB-600-XL Leukocyte Reduction Filtration System for Whole Blood with CPD Anticoagulant and SOLX Additive Solution (CBER)
  • Ipsen warns of shortages of its orphan drug Increlex (Fierce Pharma)
  • Lupin gets USFDA nod for oral contraceptive drug (India Times)
  • Pfizer Presents Phase 3 Safety And Immunogenicity Data On Prevenar 13 In Adults Aged 18 To 49 Years (Pfizer)
  • Lilly expects to submit five drugs for US approval in 2013 (PMLive)
  • Biosimilar Vs. Therapeutic Protein Immunogenicity: Industry Makes Distinction (The Pink Sheet) ($)
  • REMS Can't Help Endo's Aveed - Won't Address Unpredictable Safety Events, FDA Advisors Say (The Pink Sheet) ($)
  • Targeted Therapies On FDA's Orphan Designation Radar (The Pink Sheet) ($)
  • California Introduces New Compounding Legislation (Scout)
  • FDA fast tracks Sanofi and KaloBios' novel biologic for Pseudomonas aeruginosa (Center Watch)
  • PhRMA report lists 241 drugs under development for blood cancer (DSN)
  • USA Today Editorial Board: Give FDA More Compounding Powers (USA Today)
  • Critics see conflict of interest as Obama admin advises doctors on prescriptions (The Daily Caller)
  • Medical Devices
  • Court rules that FDA has the inherent authority to rescind a 510(k) substantial equivalence determination if it does so within a reasonable period of time (FDA Law Blog)
  • Device Adverse Event Reports Hit All-Time High (The Gray Sheet) ($)
  • Devicemakers Hope Cardio Registry Will Simplify Postmarket Process (FDA News) ($)
  • DePuy wins FDA supplemental approval for ceramic hip implant (Mass Device)
  • Another Alaris recall for CareFusion (Mass Device)
  • NinePoint's NvisionVLE Gets FDA Cleared for Esophageal Tissue Imaging (MedGadget) (Ninepoint)
  • Class 1 Recall: GemStar Infusion System for Battery Failure (FDA)
  • Class 1 Recall: SERVO-i ventilator system for Battery Failure (FDA)
  • Class 1 Recall: Newport Medical Instruments HT70 and HT70 Plus ventilator Power Pac batteries for Battery Failure (FDA)
  • FDA: Home Use Devices Should Be as Intuitive as iPhones (FDA News) ($)
  • Insuline pump hits FDA obstacle (Fierce Medical Devices)
  • New Docket Comments on Petition to Reclassify Cranial Electrotherapy Stimulator (FDA Docket)
  • Assorted
  • Sequester Will Hinder Drug, Device Reviews, FDA Head Says (Law 360) ($)
  • User Fee Exemption From Sequester Could Take Flight (The Pink Sheet) ($)
  • Comment Request: Request for Human Embryonic Stem Cell Line To Be Approved for Use in NIH-Funded Research (NIH)
  • FDA's Russell "Rusty" Katz Honored for Research on Alzheimer's (FDA)
  • CMS to discuss genetic tests for cancer (BioCentury)
  • CVS Caremark offers proper medication disposal (UPI)
  • HHS would increase rewards for reporting fraud to nearly $10 million (DHHS)
  • The Pitts and the Pendulum: Swinging Toward a Pharma Social Media Future (Pixels and Pills)
  • Government and Budget
  • Regulatory czar pick is an unknown in the battle over new rules (The Hill)
  • Obama's Next Regulatory Czar (CPR Blog)
  • US Capitol Capsule: National network aims to make patient data 'actionable' (SCRIP Intelligence) ($)
  • Helium bill easily passes House in 394-1 vote (The Hill) (Science Insider)
  • Upcoming Meetings and Events
  • 29 April 2013: Accessible Medical Device Labeling in a Standard Content and Format (FDA)
  • 29 April 2013: Meeting of the Risk Communication Advisory Committee (FDA)
  • 29 April 2013: Margaret Hamburg to Appear at Milken Institute Conference on 'The Promise of the Bioscience Century' (Milken)
  • 30 April 2013: Meeting of the Risk Communication Advisory Committee (FDA)
  • 2 May 2013: Meeting of the Oncologic Drugs Advisory Committee (FDA)
  • 2 May 2013: Meeting of the General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee (FDA)
  • 3 May 2013: Joint Meeting of the Medical Imaging Drugs Advisory Committee and Oncologic Drugs Advisory Committee (FDA)
  • Other Upcoming FDA Advisory Committee Meetings and Topics (FDA)

International

  • Teva discovers sophisticated fakes of popular drug (Financial Times)
  • India Mulls Local Market Ban Of Drugs Banned In Any Of Six Major Markets (PharmAsia News) ($)
  • European Medicines Agency recommends approval of first treatment for pseudobulbar affect (EMA)
  • Two new cancer drugs recommended in Europe (PMLive)
  • European Medicines Agency recommends approval of combined advanced-therapy product (EMA)
  • Recommendation to restrict the use of Protelos/Osseor (strontium ranelate) (EMA)
  • CHMP backs Xtandi, Erivedge, Nuedexta (BioCentury) (Roche) (Pharma Times)
  • Pfizer appealing CHMP ruling on RA treatment Xeljanz (Fierce Pharma)
  • GSK files umeclidinium for COPD in Europe (Pharma Times)
  • EGA president calls on Member States to boost market access for biosimilars in the EU (Biosimilar News)
  • IQWiG says some men with metastatic prostate cancer can benefit from J&J's Zytiga (The Pharma Letter) ($)
  • India's CDSCO to Zonal Offices: Keep Records on Clinical Trials (CDSCO)
  • Little support for pharma MNCs on patent issue (India Times)
  • Drugmakers Say Aussie 'Sunshine' Bill No Substitute for Self-Regulation (FDA News) ($)
  • EMA plans for GVP Module VI revision (Pharmertalk)
  • Australia's TGA Redefines the term "Audit" (TGA)
  • CFDA issues The First Drug Quality Announcement of 2013 (CFDA)

General Regulatory and Interesting Articles

  • Where's the Balance Between Innovation and Value? (BioCenturyTV)
  • Tiny Sponge Soaks Up Venom in Blood (Scientific American)
  • How Lasers and Glue Help to Weld Tissue Ruptures (Scientific American)
  • Anti-Drug PSAs: Do They Work? (NPR)
  • Intel and Knight Cancer Institute want to make genetic analysis part of all patient care (Med City News)

Regulatory Reconnaissance #55 - 29 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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