Regulatory Reconnaissance (18 April 2013)

Posted 18 April 2013 | By Alexander Gaffney, RAC 

Good morning and welcome to another edition of Regulatory Reconnaissance.

In the US, GSK/Theravance's new lung drug gets approval from an FDA panel, a report chides FDA for not following up on drugs approved with faulty testing, FDA reviewers express concern about a Low-T treatment, Alkermes' potential blockbuster antidepressant gets good Ph II results, GSK manufacturing delays cause a shortage, FDA releases 12 new 483's on deficient compounders, GPhA announces its support of a decision that delays generics, a circuit court kills a failure-to-warn suit, Baxter gets a warning letter, CDRH is working to update a guidance document on appeals, more glucose meter recalls, FDA's Class III device decisions are called 'curious,' and a warning letter to a supplement company alleges advertising deficiencies.

Abroad, EMA publishes its annual report, an upcoming meeting will discuss ENVI's proposed medical device regulation framework, a breast implant trial in France gets underway, a Chinese manufacturer takes a huge earnings hit after dealing with contaminated capsules last year, a CEO blasts second-guessing of EMA's methodologies, a new EU IVD proposal is reviewed, Australia's TGA issues warnings, and Cipla launches a new biosimilar product that is manufactured in China.

Plus: Could nutraceuticals be the next big growth area for pharmaceutical companies? And what regulatory challenges does that raise?

Five in Focus

  1. FDA advisory panel backs Glaxo/Theravance lung drug (Reuters) (Medscape) (The Pink Sheet) (Pharma Times) (Fierce Biotech) (RTT) (BioCentury) (SCRIP Intelligence) (The Pharma Letter) (Med Page Today)
  2. European Medicines Agency publishes 2012 annual report (EMA) (Report)
  3. Victims of breast implants seek compensation in France (Reuters) (EurActiv) (AP) (NYTimes)
  4. Double Dose: In Second Case of Flawed Drug Research, FDA Response Was Slow and Secretive (ProPublica)
  5. CDRH Working to Update Appeals Guidance for Consistency with FDASIA (FDA Law Blog)


Medical Devices
  • Baxter Hit With Warning Letter for Sigma Spectrum Infusion Pump (FDA) (Fierce Medical Devices)
  • CDRH Working to Update Appeals Guidance for Consistency with FDASIA (FDA Law Blog)
  • Abbott Initiates Voluntary Recall of FreeStyle lnsulinx Blood Glucose Meters in the United States (FDA)
  • J&J Subsidiary Lifescan Issues Another Recall Regarding its OneTouch Ultra Blood Glucose Meters, This Time Because the Meter May Display Incorrect Results (FDA)
  • Curiouser and Curiouser… Petitioner on Class III Devices Gets an Answer from FDA (MDDI)
  • Could "sunshine" rules squash medical device innovation? (Mass Device)
  • Should FDA Really be Making an Adverse Event Reporting App? (Placebo Control)
  • GE Issues a Class 2 Recall for a Medical Software System Server (FDA)
  • FDA Clears Molnlycke Transfer Dressing That Offers Reduction in Trauma and Infection Risk (Infection Control Today)
  • FDA Approves FibroScan(R) For Non-Invasive Liver Diagnosis (Medical News Today)
  • US Court of Appeals Rules that Off Label Promotion May Be Treated as Racketeering in Civil Litigation (Policy and Medicine)
  • Enforcement Report - Week of April 17, 2013 (FDA)
  • FDA Pre-Approval of Dietary Supplements Debated (Natural Products Insider)
  • Landmark Trial for Personalized Medicine Coming Soon: NGS Approval May Be One Offshoot of Lung Cancer "Master Protocol" (RPM Report) ($)
  • CDISC and C-Path Release New Kidney Disease Data Standard for use in Clinical Trials (CDISC)
  • Warning Letter to Supplement Company Alleges Misbranding, Advertising Issues and CGMP Violations (FDA)
  • Get Your Facts Fast - FOIA Requests May Be Expedited (Law 360) ($)
Government and Budget
  • Medical device tax: Repeal efforts hinge on "prearranged" deal with the Senate, Reps say (Mass Device)
Upcoming Meetings and Events
  • 15 April 2013: Supreme Court Hears Case Between the Association for Molecular Pathology v. Myriad Genetics, Inc on Whether Genes May be Patented (SCOTUS Blog)
  • 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)
  • 26 April 2013: Senate Appropriations Committee to Markup FDA Bill (Appropriations)
  • Other Upcoming FDA Advisory Committee Meetings and Topics (Eye on FDA)


General Regulatory and Interesting Articles

Regulatory Reconnaissance #48 - 18 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

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