Regulatory Focus™ > News Articles > Regulatory Reconnaissance (19 April 2013)

Regulatory Reconnaissance (19 April 2013)

Posted 19 April 2013 | By Alexander Gaffney, RAC

Good morning and welcome to another edition of Regulatory Reconnaissance. We're trying out a new summary model today in the hopes of making Recon easier for you to read. We hope you enjoy.

In Focus: US
  • FDA's Margaret Hamburg Asks Congress to Shield User Fees from Sequestration
  • FDA panel split on safety of testosterone drug Aveed
  • Vertex's Combo Therapy CF Treatment Gets Statistically Significant Test Results
  • New and Troubling Signals are Associated With Diabetes Drugs
  • Former FDA Deputy Commissioner Gottlieb Thinks the Right Incentives Aren't in Place for Medical Countermeasures
  • Abbott Announces FDA Approval of the Tecnis Toric Intraocular Lens for Cataract Patients
  • 2nd DePuy ASR Hip Trial Ends In Defense Verdict For Johnson & Johnson
  • Vitamin and Supplement Industry Needs to 'Wake up' to Massive Recalls, Says Analyst
In Focus: International
  • Clinical trials debate shifts from research to transparency ahead of EU vote
  • India Government Said To Reconsider Ban On Pharma Gifts To Doctors
  • Takeda rapped over quality control failure in Japan
  • NICE Rejects Reimbursement for Avastin
  • Health Canada Releases New eCTD Format
  • Key deliverable of Falsified Medicines Directive achieved
  • Latvian Pharmaceutical Facility Explodes

US

Pharmaceuticals/Biotechnology
  • FDA panel split on safety of testosterone drug Aveed (AP) (Reuters) (Med Page Today) (The Pink Sheet) (WSJ) (Medscape) (FDA News)
  • Vertex's Combo Therapy CF Treatment Gets Statistically Significant Test Results (Fierce Biotech) (SCRIP Intelligence) (Xconomy) (Reuters) (BioCentury) (Forbes) (Pharma Times) (Bloomberg)
  • Troubling New Signals? Diabetes Drugs & Adverse Event Reports (Pharmalot)
  • Roche sees another Rituxan biosimilar trial bite the dust (Fierce Biotech)
  • BioAlliance gains US win for Sitavig single-use cold sore med (SCRIP Intelligence)
  • FDA's Rejection Of Generic OxyContin May Have Side Effects (NPR)
  • Depomed Hits Endo With Patent Suit Over Opana ER (Law 360) ($)
  • Former FDA Deputy Commissioner Gottlieb: Does FDA and BARDA Need to Re-Tool Incentives for Investment in Medical Countermeasures? (AEI)
  • Experts Express Mixed Thoughts on Canagliflozin Approval (Medscape News)
  • Stemming the Global Trade in Falsified and Substandard Medicines (JAMA)
  • Workshop: Clinical Trial Design Issues - Drug & Device Development for Localized Prostate Cancer (FDA)
  • Workshop: Clinical Trial Design Issues - Development of New Therapies for Non-Muscle Invasive Bladder Cancer (FDA)
  • SK Biopharmaceuticals Announces U.S. FDA's Authorization of IND for SKL15508 (Business Wire)
  • Operator of Online Drug Company That Sold Misbranded Drugs Pleads Guilty to Failing to Pay Taxes (FDA)
  • FDA's Oxy action has side effects; costs stay high for those in true need (Kentucky Herald-Leader)
  • Legal Flash: 8 Regulations set to impact the Pharma & Biotech Industry in 2013 (Pharma IQ)
  • Comment Request; Guidance for Industry on Hypertension Indication: Drug Labeling for Cardiovascular Outcome Claims (FDA)
  • FDA Approves Three Labeling Changes for UCB Inc's Vimpat (Lacosamide), and one for Baxter's Dobutamine HCl in Dextrose (FDA)
  • FDA Approves Manufacturing Change for Medici's Solodyn (Minocycline HCl) and Mission Pharma's Binosto (Alendronate Sodium) (FDA)
  • FDA Approves Indovo Remedies's Generic Glimepiride (ANDA #202112) (FDA)
Medical Devices
  • Abbott Announces FDA Approval and U.S. Launch of the TECNIS Toric Intraocular Lens for Cataract Patients (Abbott) (Mass Device) (Fierce Medical Devices)
  • 2nd DePuy ASR Hip Trial Ends In Defense Verdict For Johnson & Johnson (Lexis Nexis) (Law 360) ($)
  • FDA clears Echosens FibroScan liver disease device (Mass Device)
  • Stryker Orthopaedics - ShapeMatch Cutting Guide: Class 1 Recall (FDA)
  • Covidien Issues Voluntary Recall of Power Pac Batteries for 
  • Newport HT70 and HT70 Plus Ventilators (FDA)
  • Siemens IVD Hit With Class 2 Recall Due to Low Bias in Therapeutic Range (FDA)
  • Edwards Recalls a Pressure Monitoring Set Due to Multiple Complaints, Error Could Lead to Dilution of Blood Samples (FDA)
  • How to Risk-Manage Your Supplier Quality: A Roundtable Discussion (MDDI)
  • OMB Approval for "Guidance for Industry, FDA Staff, and Foreign Governments: Fiscal Year 2012 Medical Device User Fee Small Business Qualification and Certification" (FDA)
  • OMB Approval: "Electronic Submission of Medical Device Registration and Listing" (FDA)
  • Comment Request; Clinical Laboratory Improvement Amendments Waiver Applications (FDA)
  • Should the FDA Have the Authority to Enforce Penalties on Improper Needle Disposal? (Kulkarni Law Blog)
Assorted
  • Hamburg Asks Congress to Shield User Fees from Sequestration (FDA News) ($)
  • Massive Drug Recalls are a Wake-Up Call for Vitamin and Supplement Industry (Forbes)
  • FDA Spending $3 mil. On Compounding Oversight, Maybe More If Authority Expanded (The Pink Sheet) ($)
  • Journal, Authors Defend Oxygen Saturation Trial (Med Page Today)
  • FTC Loses Again; Court of Appeals Affirms Lower Court's Determination that Garden of Life's Expert Opinion Constitutes Competent and Reliable Evidence (FDA Law Blog)
  • Advisory Council on Blood Stem Cell Transplantation; Notice of Meeting (HRSA)
  • Four Men Indicted In Mojo Nights Misbranded Dietary Supplement Case (Safe Medicines)
  • Opinion: ProPublica Dollars for Doctors Articles Miss the Mark (Policy and Medicine)
Government and Budget
  • Room for daylight on medical device tax repeal? (Mass Device)
Upcoming Meetings and Events
  • 17 April 2013: Cellular, Tissue and Gene Therapies Advisory Committee Meeting (FDA)
  • 17 April 2013: Pulmonary-Allergy Drugs Advisory Committee Meeting Announcement (FDA)
  • 18 April 2013: Joint Meeting of the Advisory Committee for Reproductive Health Drugs and Drug Safety and Risk Management Advisory Committee (FDA)
  • 18 April 2013: A Financial Review of the Department of Health and Human Services and Its FY 2014 Budget (E&C)
  • 19 April 2013: Senate Appropriations Subcommittee on Agriculture and FDA to Hold Hearing, Hamburg Will Testify (Appropriations)
  • 25-26 April 2013: Clinical Chemistry and Clinical Toxicology Devices Panel of the Medical Devices Advisory Committee Meeting (FDA)
  • 26 April 2013: Senate Appropriations Committee to Markup FDA Bill (Appropriations)
  • Other Upcoming FDA Advisory Committee Meetings and Topics (Eye on FDA) (FDA)

International

  • New Approach to Evaluation of Over the Counter Medicines in Australia and New Zealand (Health Australia) (TGA)
  • Clinical trials debate shifts from research to transparency ahead of EU vote (EurActiv)
  • India Government Said To Reconsider Ban On Pharma Gifts To Doctors (PharmAsia News)
  • Takeda rapped over quality control failure in Japan (Pharmafile)
  • Another NICE knockback for Avastin (Pharma Times)
  • Health Canada Releases New eCTD Format (Health Canada)
  • Key deliverable of Falsified Medicines Directive achieved (EMA)
  • Latvian Pharmaceutical Facility Explodes (BioSpace)
  • UK Appeals Court Sends Singulair Arguments To EU Court (Law 360) ($)
  • Aussie Study Finds Generics Makers Also Want Patent Protections (PharmAsia News) (The Pharma Letter) ($)
  • Draft guidance from NICE recommends Bayer's Xarelto PE and DVT (The Pharma Letter) ($) (BioCentury)
  • S. Korea's Celltrion Cancels Phase III Trials Of Lymphoma Generic (PharmAsia News) ($)
  • Will Brazil grab the emerging-markets popularity crown? (Fierce Pharma)
  • Germany looks at price cuts on big-selling drugs (Pharma Times) (Reuters) (Bloomberg) (BioCentury)
  • China To Launch Drug Producer Price Monitoring System (PharmAsia News) ($)
  • Shortage of vaccine restrains Indian govt from further roll-out of pentavalent shots (PharmaBiz)
  • British Fake Pharmacy Actually Selling Counterfeit Drugs From Pakistan: Four Sentenced (Safe Medicines)
  • Progress on better access to medicines for patients in Europe (The Pharma Letter) ($)
  • Meeting Minutes of Second Expert Committee of India's MHFW (CDSCO)
  • India must emerge as leader in low-cost vaccines by 2020: Kalam (India Times)
  • Health Canada Rolls out a New Adverse Reporting Button (Health Canada)
  • France's ANSM Says Roche Has Withdrawn Marketing Authorization for Rohypnol (Fluniteazepam 1 mg) (ANSM)
  • Sandoz Withdraws Lots of Amoxicillin Capsules Due to Particle Contamination (ANSM)

General Regulatory and Interesting Articles

  • The Global Fund and pharmacovigilance systems in resourcelimited settings (The Lancet)
  • Stemming the Global Trade in Falsified and Substandard Medicines (JAMA)
  • Pharmacovigilance Using Clinical Notes (Clinical Pharmacology & Therapeutics)
  • Big Data and Pharmacovigilance: Using Health Information Exchanges to Revolutionize Drug Safety (SSRN)

Regulatory Reconnaissance #49 - 19 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 editor@raps.org.


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