Regulatory Focus™ > News Articles > Regulatory Recon: Global Regulators Crack Down on Fake Meds (22 May 2014)

Regulatory Recon: Global Regulators Crack Down on Fake Meds (22 May 2014)

Posted 22 May 2014 | By Alexander Gaffney, RAC 

Regulatory Recon: Global Regulators Crack Down on Fake Meds (22 May 2014)

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing. Read anything we might be interested in sharing? Let us know: news@raps.org.

In Focus: US

  • Celebrating 30 Years of the Hatch-Waxman Amendments (FDA Law Blog)
  • FDA’s “Voice of the Patient:” Listening to Those Most Affected by Their Disease and Treatments (FDA)
  • Emerging Question On OTC Switches: Too Many Choices For Consumers? (Pink Sheet-$)
  • FDA approves first molecular (gene-based) test to determine red blood cell types in transfusion medicine (FDA)
  • Warning Letter for Tampon Manufacturer (FDA)
  • Improving Documentation of GMP Procedures (NPI)
  • Can FDA Employees be Deposed in a Trial? (D&D Law)

In Focus: International

  • Operation PANGEA VII Concludes (ANSM) (Reuters)
  • EFPIA Launches Clinical Trials Open Data Page (EFPIA)
  • Which way now? Two critical EU Commission reports on medtech regulations in the wings (Clinica-$)
  • India to Exempt Some Drug Packages From Barcoding Rule (India Times)
  • An Overview of Biosimilars and the Biosimilar Pathway in India (NLR)
  • China anti-graft watchdog visits Roche amid pharma crackdown (Reuters) (Bloomberg)

US: Pharmaceuticals/Biotechnology

  • Celebrating 30 Years of the Hatch-Waxman Amendments (FDA Law Blog)
  • FDA’s “Voice of the Patient:” Listening to Those Most Affected by Their Disease and Treatments (FDA)
  • Emerging Question On OTC Switches: Too Many Choices For Consumers? (Pink Sheet-$)
  • Novo preps for FDA panel hearing on lucrative obesity use for liraglutide (Fierce) (MedCity News) (BioCentury)
  • HHS Watchdog Updates Policies On Drug Charity Kickbacks (Law 360-$)
  • A Case for Stage 3 Continued Process Verification (Pharma Manufacturing)
  • Paging FDA… Marijuana Sizzurp Hits the L.A. Market (LA Weekly)
  • Counties sue narcotics makers, alleging 'campaign of deception' (LA Times)
  • PhRMA Looking to Hire New Director of Scientific and Regulatory Affairs (PhRMA)
  • Judge Won't Revive FCA Whistleblower Claims Against Bayer (Law 360-$)
  • House Approps Bill's Lack Of FDA Compounding Funds Draws DeLauro's Ire (IHP-$)
  • Unniversity of Minnesota drug study criticism grows (Fox9)
  • Third Annual ISPE/FDA Current Good Manufacturing Practices Conference (FDA)
  • Teva Pharmaceutical recalls 38,858 bottles of drugs made by Emcure Pharmaceuticals in US market (India Times)

US: Pharmaceuticals and Biotechnology: Clinical Study Results, Filings and Designations

  • Intercept Pharmaceuticals Didn't Disclose Cholesterol Data (WSJ-$)
  • Novartis' COPD therapy Ultibro Breezhaler meets goals in early clinical trial (MedCityNews) (PMLIve)
  • First Ph III data on Boehringer’s fixed-dose combo tiotropium plus olodaterol in COPD (Pharma Letter-$) (Press) (BioCentury)
  • Antidote for rapid reversal of Pradaxa (dabigatran etexilate) progresses into next stage of clinical investigation with study in patients (Press)
  • Santhera Reports Positive Outcome for Catena/Raxone in Phase III DMD Trial Supported by Additional Respiratory Function Data (Press)

US: Pharmaceuticals and Biotechnology: General

US: Medical Devices

  • FDA approves first molecular (gene-based) test to determine red blood cell types in transfusion medicine (FDA)
  • Warning Letter for Tampon Manufacturer (FDA)
  • FDA Approves New Injected Material to Treat Knee Pain (FDA)
  • Medical Device Recalls: Prepare in Advance and Minimize Risk (Medical Design)
  • Boston Scientific: Lotus TAVI meets endpoint in clinical trial (Fierce)
  • FDA Advisory on Surgical Device Divides Doctors (WSJ-$)
  • FDA OKs expansion of Abiomed's Impella RP trial (Mass Device)
  • HealthPatch MD Vitals, Falls, and Posture Monitoring Patch Wins FDA Clearance (MedGadget)
  • Class 1 Recall for Maquet Datascope's IntraAortic Balloon Pump (FDA)
  • TAVI: FDA OKs Direct Flow Medical's U.S. pivotal trial for heart valve (Mass Device)

US: Dietary Supplements

  • Supplement GMP Warnings Note Qualifying Suppliers, CMOs (Tan Sheet-$)
  • Improving Documentation of GMP Procedures (NPI)

US: Assorted And Government

  • FDA’s Responsibilities Require Significantly More Funding (Strengthen FDA)
  • On Deposing FDA Employees (D&D Law)
  • Supreme Court Declines to Review Important False Claims Act Issue (Policy and Medicine)
  • Clinical Investigator Hit in Extensive Warning letter (FDA)
  • Manufacturers seek badly-needed volunteers to test drugs and other therapies (WaPo)
  • FDA Enforcement Report (FDA)
  • Patent troll bill poses bridge too far for Senate (SCRIP-$)

Europe

  • Operation PANGEA VII Concludes (ANSM) (Reuters)
  • EFPIA Launches Clinical Trials Open Data Page (EFPIA)
  • Which way now? Two critical EU Commission reports on medtech regulations in the wings (Clinica-$)
  • The Walking Dead: Renal Denervation In Europe Just Can't Be Stopped (Forbes)
  • Veloxis Receives Positive Opinion from CHMP for Envarsus(R) for Treatment of Both Kidney and Liver Transplant Patients (Press)
  • EDQM: List of texts adopted at the March 2014 session of the PhEUR Commission (EDQM)
  • Pharmaceutical industry ‘not ready’ to manage XEVMPD requirements according to new ProductLife Group research (Press)
  • TxCell SA : Col-Treg Granted Advanced Therapy Medicinal Product (ATMP) Classification by the European Medicines Agency (Press)

India

  • India to Exempt Some Drug Packages From Barcoding Rule (India Times)
  • An Overview of Biosimilars and the Biosimilar Pathway in India (NLR)

Japan & China

  • China anti-graft watchdog visits Roche amid pharma crackdown (Reuters) (Bloomberg)
  • China’s Legislative Affairs Office of the State Council Extends Comment Period for Proposed Rules Implementing the Revised Medical Device Regulation (Inside Medical Devices)
  • Edison's EPI-743 Gets Orphan Designation in Japan (Press)

Canada

  • Canadian-developed test uncovers fake drugs in 10 minutes (Sun News)
  • Is Canada next to ban active ingredient in most antibacterial soaps? (Vancouver Sun)
  • AbbVie files New Drug Submission to Health Canada for its investigational, all-oral, interferon-free therapy for the treatment of hepatitis C (Press)

General Regulatory And Interesting Articles

  • Sorry, But So Far War on Cancer Has Been a Bust (Scientific American)
  • If You Take a Prescription Medicine, You Have Clinical Trial Volunteers to Thank (PhRMA)

Regulatory Reconnaissance #324 – 22 May 2014

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.

A story's inclusion in Regulatory Reconnaissance does not imply endorsement by Regulatory Focus or RAPS.


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