Regulatory Focus™ > News Articles > Regulatory Reconnaissance (11 June 2013)

Regulatory Reconnaissance (11 June 2013)

Posted 11 June 2013 | By Alexander Gaffney, RAC

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

In Focus: US

  • Boston Scientific warns of labeling issues in balloon dilators, catheters (Mass Device)
  • Government Agencies Launch 'Challenge' to Better Understand Genetic Influences on Cytotoxic Reponses to Common Chemicals (Business Wire)
  • Baxter Bosses Sued Over $588M Pump Recall, Plasma Prices (Law 360)
  • Dying Girl Needing Lung Forces Change in US Organ Donation Policy (Bloomberg)
  • Delaware Biosimilars Legislation Introduced To Notify Patients of Changes to Prescriptions (BIO)

In Focus: International

  • Announcement due shortly on new UK MHRA chief (SCRIP)
  • Sanofi's "painful" MS drug development saga may be ending (Reuters) (Fierce)
  • New ED treatment from Apricus Bio gets EU nod (Pharma Times)
  • India's Health ministry plans effective drug alert system, including placing newspaper ads (PharmaBiz)
  • COFEPRIS strengthens ties to Mexican industry group, plans restructuring (Mass Device)
  • APEC Supply Chain Regulatory Harmonization Effort Gaining Traction (IPQ)

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

US

Pharmaceuticals/Biotechnology
  • SOBI gets FDA approval to manufacture substance for Kineret with partner Boehringer Ingelheim (Pharma Letter)
  • Government Agencies Launch 'Challenge' to Better Understand Genetic Influences on Cytotoxic Reponses to Common Chemicals (Business Wire)
  • Cumberland Pharmaceuticals Reports FDA Approval For Updated Acetadote Labeling (Cumberland)
  • Delaware Biosimilars Legislation Introduced To Notify Patients of Changes to Prescriptions (BIO)
  • FDA Announces Minor Use/Minor Species (MUMS) Grant Program Request for Applications Open Period due August 16, 2013 (FDA)
  • Neumedicines Receives an Award of $8.3 Million from BARDA for Continued Development of HemaMax as a Countermeasure to Acute Radiation Exposure (Neumedicines)
  • Op-Ed: State-based drug tracking puts Americans at risk (CEI)
  • FDA Decision on Discontinued Cordran Provides ANDA Lifeline for IGI Labs (FDA) (FDA News)
Medical Devices
  • Boston Scientific warns of labeling issues in balloon dilators, catheters (Mass Device)
  • Does J&J's latest metal hip lawsuit boost the number to 10,001? (Fierce)
  • Exact Sciences completes Cologuard PMA submission (BioCentury)
  • Non-Powered and Powered Patient Lifts: MedSun Small Sample Survey Summary (FDA)
  • Meridian Bioscience Receives FDA Clearance for New Molecular Amplification Test: illumigene® Mycoplasma (Meridian)
  • Teleflex Receives FDA Clearance for ARROW NextStep Retrograde Femoral Length Dialysis Catheters (Teleflex)
  • Baxter Bosses Sued Over $588M Pump Recall, Plasma Prices (Law 360)
  • Doctors will 'teach' IBM's Watson to diagnose lung cancer, plan treatments (Med City News)
  • Six attempts at a smartphone-connected breathalyzer (MobiHealth News)
  • Senators Tout New Public Health Law Giving Obama Administration Ability to Respond Quickly to Burgeoning Middle East Respiratory Disease (Senate)
Assorted and Government
  • Can Consumer Health Products Delightfully Deliver Medical Benefit -- Or Just Truthiness? (Forbes)
  • National Biodefense Science Board; Call for Nominees (Federal Register)
  • John-Michael Sauer joins C-Path (BioCentury)
  • Dying Girl Needing Lung Forces Change in US Policy (Bloomberg)
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)
  • 18 June 2013: Understanding the Regulatory Landscape for Adaptive Design Trials (RAPS)
  • 19-20 June 2013: Regulatory Education for Industry (REdI) Conference (FDA)
  • 29 June 2013: Clinical Development Programs for Opioid Conversion (FDA)
  • Other Upcoming FDA Advisory Committee Meetings and Topics (FDA)

Europe

  • Announcement due shortly on new UK MHRA chief (SCRIP)
  • Sanofi's "painful" MS drug development saga may be ending (Reuters) (Fierce)
  • New ED treatment from Apricus Bio gets EU nod (Pharma Times)
  • France Enacts New Use Restrictions on Protelos due to Increased Heart Attack Risk (ANSM)
  • PRAC: Draft agenda of meeting on 10-13 June 2013 (EMA)
  • ViroPharma Receives Orphan Drug Designation For Maribavir In Europe (ViroPharma)
  • The Tangled Destinies of Europe's UDI, Eudamed Database and Medical Device Regulation (MedTech Insider)
  • Roche gets Swiss approval for skin cancer drug (Reuters)
  • EU and Gates Foundation sign disease research agreement (EurActiv)

Asia

  • India's Health ministry plans effective drug alert system, including placing newspaper ads (PharmaBiz)
  • APEC Supply Chain Regulatory Harmonization Effort Gaining Traction (IPQ)
  • Novartis India Probes Sales Practices For Galvus; Heads Roll (PharmAsia News)
  • Singapore's data protection authority clarifies data protection approach (Global Reg. Enforcement Blog)
  • GSK fires senior Chinese scientist over data fabrication (PMLive) (BioCentury) (Pharmalot) (GSK)
  • APDCA seizes drugs & drug pellets worth Rs.13 lakhs from Zelos Healthcare and Allanthus Biotech in Hyderabad (PharmaBiz)

Other International

  • COFEPRIS strengthens ties to Mexican industry group, plans restructuring (Mass Device)

General Regulatory and Interesting Articles

  • A path to lower-risk painkillers (EurekAlert)
  • Why we should be spending more on pricey cancer drugs (AEI)
  • The Promise In Unraveling The Mysteries Of Rare Diseases (NPR)
  • Triple Threat: Middle East Respiratory Virus And 2 Bird Flus (NPR)

Regulatory Reconnaissance #85 - 11 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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