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

Regulatory Reconnaissance (13 May 2013)

Posted 13 May 2013 | By Alexander Gaffney, RAC

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

In Focus: US

In Focus: International

  • After Seven Years, How are Biosimilars Doing in the EU? (BioCenturyTV)
  • China biologics on the rise despite regulatory issues  (SCRIP Intelligence)
  • Drugs giants used Communist East Germany for 'illegal' trials (The Independent)
  • Local Indian Committees to Conduct Annual Inspections of Trial Sites (Outsourcing Pharma)
  • Germany's New Drug Register To Help Tackle Supply Shortages, But Larger EU Problem Looms (The Pink Sheet)

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

US

Pharmaceuticals/Biotechnology
  • FDA: Foreign Manufacturers to Help Alleviate US Infant Drug Shortages Next Week (Outsourcing Pharma)
  • Report Pokes Holes In FDA Celexa Dose Warning (FDA News)
  • Drug Companies See Path To Legal Off-Label Marketing Throuh Caronia Decision (Law 360)
  • Did FDA Make a Huge Blunder Approving Merck's Liptruzet? (MPT) (Forbes) (Pharmalot) (Counter: MPT)
  • Today last day for morning-after pill appeal (AP)
  • Lilly Announces Enzastaurin Phase III Study Did Not Meet Primary Endpoint in Diffuse Large B-Cell Lymphoma (Eli Lilly) (BioCentury) (Fierce Biotech) (DDD Mag)
  • What's Breakthrough Status Worth? Analysts Ask, But Companies Don't Have Answers (The Pink Sheet)
  • FDA Approves Sandoz's Generic Arthrotec (Diclofenac Sodium/Misoprostol) (ANDA #200158)(FDA)
  • Pew Testimony on the Safety of Compounding Pharmacies (Pew)
  • Compounders Counter FDA Call for More Inspection Authority (FDA News)
  • NECC Dodged Patient-Specific Compounding Rule, Docs Say (Law 360) (AP)
  • Why Does Arena's Obesity Drug Have Abuse Potential? (Forbes)
  • Research on Use of Structured Product Labeling to Identify Prescription Drugs With Boxed Warnings Finds Numerous Inconsistencies (Business Wire)
  • BIO Weighs in on the Proposed Adoption of the ICH E2C (R2) Standard (FDA Docket)
  • Aveo Hid Kidney Drug's Higher Death Risk, Shareholder Says (Law 360)
  • Star Scientific Shareholders Sue Over Drug Claims, DOJ Inquiry (Law 360)
  • Illinois Jury Awards $2.2M To Widower In 1st Humira Infection Case To Go To Trial (Lexis Nexis)
  • Which Came First? Alogliptin Avoids Possible Exclusivity Dispute (RPM Report)
  • Additional Lots Added: Voluntary Nationwide Recall of 21 Lots of Piperacillin and Tazobactam for Injection, USP 40.5 Grams Due to Possibility of Precipitation / Crystallization in IV Bag or IV Line Upon Reconstitution (Hospira/Apotex) (FDA)
  • Arsenic Levels In Chicken Increased By Livestock Drug (Medical Daily)
  • Determination That REV-EYES (Dapiprazole Hydrochloride Ophthalmic Solution), 0.5%, Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness (FDA)
Medical Devices
  • Congressman: Revised Legislation to Create FDA Office of mHealth Coming Soon (Med City News)
  • Medtronic Issues Statement on iPad Interference Study (Medtronic)
  • Device Industry Largely Supports FDA's New Proposal On Pediatric Data Submission (The Gray Sheet)
  • Sorin Group Announces FDA Approval and U.S. Launch OF SMARTVIEWT Remote Monitoring Solution for Patients with Implanted Cardiac Defibrillators (Business Wire)
  • Signos RT, or Sonimage P3, Handheld Ultrasound Receives FDA Approval (MedGadget)
  • Intuitive Surgical warns on da Vinci scissor crack risk (Mass Device)
  • St. Jude Gets FDA Green Light for Ellipse, Assura High Voltage Cardiac Devices (MedGadget)
  • FDA Issues 510(k) for Haemonetics Software Solution's Phlebotomy System (FDA)
  • Dental Products Panel of the Medical Devices Advisory Committee; Notice of Meeting (FDA)
  • Data From More Than 100,000 Boston Scientific Implantable Defibrillators Show Battery Longevity Projections Of Nine To 13 Years (Boston Scientific)
Assorted
  • Medicare Drug Program Fails to Monitor Prescribers, Putting Seniors and Disabled at Risk (ProPublica)
  • Analysis: Drugmakers face more scrutiny of discordant U.S. prices (Reuters)
  • Lawmakers reject Obama's request for IPAB nominations (BioCentury) (The Pink Sheet) (Mass Device)
  • Website content an extension of labeling: FDA warning letter shows companies need to 'think about their real estate space' (Nutraingredients USA)
  • Clinical Trials: Do Participants Feel Safe? (CTTI)
  • PCORI Research Applications: Fewer Than Expected, Geographically Limited (The Pink Sheet)
  • Inflammatory Bowel Drugs To Go Head-To-Head With PCORI Funding (The Pink Sheet)
  • FDA Announces Another Meeting on Patient-Focused Drug Development, This Time for HIV (FDA)
  • FDA warning letter highlights obligations of private label distributors (Nutra Ingredients USA)
  • Interview with Mary Lou Valdez, Associate Commissioner for International Programs, U.S FDA (YouTube)
  • Obama's health secretary seeks donations from companies for healthcare law (Reuters)
  • Rhode Island Legislation Would Change Regulations on Blood Supply (Scout)
  • National Vaccine Injury Compensation Program; List of Petitions Received (HRSA)
  • Not 'glamorous': Doc is universal donor for fecal transplants (NBC)
  • FDA Submission to OMB on NADAs (FDA)
Government and Budget
Upcoming Meetings and Events
  • 14-15 May 2013: E&C Committee to Markup ADUFA/ADGDUFA User Fee Bills (E&C)
  • 14-15 May 2013: E&C Committee to Markup Pharmaceutical Track and Trace Legislation (E&C)
  • 16 May 2013: OPDP Enfocement Actions Webinar (FDA)
  • 17 May 2013: NCATS Meeting (NCATS)
  • 21-22 May 2013: Orthopaedic and Rehabilitation Devices Panel of the Medical Devices Advisory Committee (FDA)
  • 22 May 2013: Meeting of the Peripheral and Central Nervous System Drugs Advisory Committee (FDA)
  • 22 May 2013: CVM's New Animal Drugs for Use in Feeds Workshop (FDA)
  • Other Upcoming FDA Advisory Committee Meetings and Topics (FDA)

International

  • After Seven Years, How are Biosimilars Doing in the EU? (BioCenturyTV)
  • China biologics on the rise despite regulatory issues  (SCRIP Intelligence)
  • Drugs giants used Communist East Germany for 'illegal' trials (The Independent)
  • Local Indian Committees to Conduct Annual Inspections of Trial Sites (Outsourcing Pharma)
  • Kenyan drug regulatory body shows keen interest to adopt Gujarat model (PharmaBiz)
  • Germany's New Drug Register To Help Tackle Supply Shortages, But Larger EU Problem Looms (The Pink Sheet)
  • Boston Scientific Receives CE Mark Approval For The Rhythmia™ Mapping System (Boston Scientific)
  • Views on the news: politics, not logic, will drive EU medtech reg outcome (Clinica)
  • Devicemakers Must 'Act Now' on Objections to EU Device Regulations (FDA News)

General Regulatory and Interesting Articles

  • Now a partner, Save the Children CEO used to protest GlaxoSmithKline price policies (Philly Pharma) (The Guardian)
  • Study Links Labor-Inducing Drug Pitocin to Adverse Events in Newborns (Drug Safety Monitor)
  • Bacteria-killing Viruses Could Make Medical Implants Safer (MIT Tech Review)
  • Nearly 50% of Patients with Cardiac Device Infections Don't Survive Beyond Three Years (Business Wire)
  • Astronaut Chris Hadfield Gives an Awesome Rendition of David Bowie's "Space Oddity" on Board the International Space Station. Because, Hey, Why Not. (YouTube)

Regulatory Reconnaissance #65 - 13 May 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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