Regulatory Focus™ > News Articles > Regulatory Reconnaissance (13 June 2013)

Regulatory Reconnaissance (13 June 2013)

Posted 13 June 2013 | By Alexander Gaffney, RAC 

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

In Focus: US

  • Drugmakers to cooperate in safety review of diabetes drugs  (Merck) (AZ/BMS) (Fierce) (The Pharma Letter) (SCRIP) (Reuters)
  • Diabetes Drugs Under Scrutiny As FDA Considers Another Study (Pharmalot)
  • AMP vs. Myriad: Case Decision Due as Early as Today (JSOnline)
  • Biosimilar Developers Seek Clarity on US FDA Draft Guidance (In-Pharma Technologist)
  • FDA Panels: Too Many Conflicts Or Too Little Expertise? (Pharmalot)
  • How the 'FDA Nine' Changed the MedTech Industry (MDDI)
  • Who's fighting digital healthcare? The little guys who print paper drug inserts (Med City News)

In Focus: International

  • Europe Drug Regulator Wants to Work With Cost Bodies, Chief Says (Bloomberg)
  • Some China API Firms Wont Have 'Written Confirmations' by July says blue inspection body (In-Pharma Technologist)
  • Another Glaxo Scandal In China: Bribing Docs To Prescribe Meds? (Pharmalot) (PharmAsia)
  • UK ministers favor trial data transparency, with caveats (SCRIP)
  • MHRA Seeks Input on Approach to EU Animal Tissue, eLabeling Regulations (FDA News)
  • Eucomed guidance clarifies RoHS compliance for medical device companies (Mass Device)
  • We trust Indian manufacturing norms: USFDA (India Times)

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

US

Pharmaceuticals/Biotechnology
  • Drugmakers to cooperate in safety review of diabetes drugs  (Merck) (AZ/BMS) (Fierce) (The Pharma Letter) (SCRIP) (Reuters)
  • Diabetes Drugs Under Scrutiny As FDA Considers Another Study (Pharmalot)
  • AMP vs. Myriad: Case Decision Due as Early as Today (JSOnline)
  • Stores Prepare to Widen Access to Plan B Pill (WSJ)
  • FDA: New Boxed Warning for Clot Risk With Immune Globulin (Medscape)
  • Ranbaxy eyes U.S. drug launches with sales exclusivity (Reuters)
  • FDA Issues Final Orphan Drug Regulations (FDA Law Blog)
  • Biosimilar Developers Seek Clarity on US FDA Draft Guidance (In-Pharma Technologist)
  • Mass. insurer end coverage of compounded drugs (AP)
  • Drugmakers' Shortage Prevention Programs Coming Up Short: Survey (FDA News)
  • Celgene bolsters case for closely watched arthritis drug with Ph3 data (Fierce) (Celgene) (Pharma Times)
  • Amgen's trebananib met trial goal, reduces risk of ovarian cancer (Reuters) (BioCentury)
  • ISPE Study Reports on Root Causes for Drug Shortages (Pharmtech)
  • FDA Comes to Grips with Fecal Transplants (Scientific American)
  • Teva, Sun Pharma to pay $2.15 billion to settle Pfizer patent suit (Reuters) (Teva) (PharmAsia News) (WSJ)
  • India's Sun To Sue Novartis in US Court To Allow Generic Before Patent Expiration (PharmAsia) (India Times)
  • VA researchers recommend delaying use of Enbrel for RA (BioCentury)
  • Pharmacist Group Voices "Serious" Concerns With State Biosimilar Bills (FDA News)
  • Jakafi (ruxolitinib) Prescribing Information Updated with Expanded Dosing Guidance and New Safety Information (Incyte)
Medical Devices
  • Unique device identification: PwC perspectives for medical device manufacturers (PWC)
  • Report: Dx companies gouging Medicare (Fierce)
  • AngioScore Announces PMA Supplement Approval Allowing a Summary of the AGILITY Coronary Bifurcation Trial Results in the AngioSculpt IFU (AngioScore)
  • Abyrx, Inc. Receives FDA 510(k) Clearance for New Absorbable Hemostatic Bone Putty (AHBP) (Abryx)
  • Washington U. spin-out Cardiac Insight hits 510(k) milestone with less than $2M (Mass Device)
  • Cordis Announces FDA Clearance of the ADROIT Guiding Catheter (Cordis)
  • The FDA Nine: 10 People Who Changed the Medtech Industry (MDDI)
Assorted and Government
Upcoming Meetings and Events
  • 11-12 June 2013: FDA/NIH/NSF Workshop on Computer Models and Validation for Medical Devices (FDA)
  • 12-13 June 2013: 16th Annual FDA-OCRA Educational Conference (OCRA)
  • 13 June 2013: 510(k) Device Modifications: Deciding When to Submit a 510(k) for a Change to an Existing Device (FDA)
  • 13 June 2013: Good Manufacturing Practice Deficiencies: Federal Health Care Enforcers' Next False Claims Act Target? (WLF)
  • 13 June 2013: Microbiology Devices Panel of the Medical Devices Advisory Committee Meeting Announcement (FDA)
  • 13 June 2013: Markup of FDA Appropriations Bill (House)
  • 14 June 2013: Public Meeting on HIV Patient-Focused Drug Development and HIV Cure Research (FDA)
  • 14 June 2013: Congressional Hearing on Prescription Drug Abuse (E&C)
  • 17 June 2013: FDA Basics Webinar: Biological Products: Part 1 (FDA)
  • 18 June 2013: Understanding the Regulatory Landscape for Adaptive Design Trials (RAPS)
  • 19-20 June 2013: Regulatory Education for Industry (REdI) Conference (FDA)
  • 25-26 June 2013: Standardizing and Evaluating Risk Evaluation and Mitigation Strategies (FDA)
  • 29 June 2013: Clinical Development Programs for Opioid Conversion (FDA)
  • Other Upcoming FDA Advisory Committee Meetings and Topics (FDA)

Europe

  • Europe Drug Regulator Wants to Work With Cost Bodies, Chief Says (Bloomberg)
  • UK ministers favor trial data transparency, with caveats (SCRIP)
  • MHRA Seeks Input on Approach to EU Animal Tissue, eLabeling Regulations (FDA News)
  • Eucomed guidance clarifies RoHS compliance for medical device companies (Mass Device)
  • GLP-1 benefits outweigh pancreatic harm, says MHRA (RPS)
  • Traceability Requirements in EU's ATMP Regulation Need Tweaking: Pfizer (FDA News)
  • NICE still backing GSK's bleeding disorder drug Revolade (Pharma Times)
  • NICE final draft guidance on Eli Lilly's Alimta negative (Pharma Letter) (PMLive)
  • Scotland's SMC issues 'no' for Alimera's Iluvien but Almirall drug wins OK (Pharma Times)

Asia

  • Some China API Firms Wont Have 'Written Confirmations' by July says blue inspection body (In-Pharma Technologist)
  • Another Glaxo Scandal In China: Bribing Docs To Prescribe Meds? (Pharmalot) (PharmAsia)
  • We trust indian manufacturing norms: USFDA (India Times)
  • Glaxo's MS drug tests put on hold after fraud claim (FT)
  • India: A drug market wrecked by government (AEI)

Other International

  • Regulators Down Under issue a hazard alert on J&J's shoulder surgery guides (Mass Device)

General Regulatory and Interesting Articles

  • Survey: Clinical trials would get more participants if docs informed patients about them (Med City News)
  • Electronic medical records 'could boost clinical trial efficiency' (PMLive)
  • First Bioengineered Blood Vessel Successfully Implanted (Scientific American)
  • Patients use OTC NSAIDs even when they have a high risk of serious side effects (EurekAlert)
  • Cheaper generic combo found as effective in RA as blockbuster Enbrel (Fierce)
  • Mystery solved? Research blames ruptured plaque for stent related blood clots (Fierce)
  • Once-a-day pill prevents HIV in drug users (NBC)
  • Drugs That Increase The Risk Of Birth Defects Also Save Mothers' Lives: Study Shines Light On Tough Decisions For Pregnant Women (Medical Daily)
  • Faldaprevir's efficacy in Asian HCV patients looking good (SCRIP) (BI)

Regulatory Reconnaissance #87 - 13 June 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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