Regulatory Focus™ > News Articles > Regulatory Reconnaissance (29 March 2013)

Regulatory Reconnaissance (29 March 2013)

Posted 29 March 2013 | By Alexander Gaffney, RAC

Good morning and welcome to another edition of Regulatory Reconnaissance. Your editor is taking the day off, as he is occasionally wont to do. But never fear: We have you covered with some reconnaissance all the same.

In the US, Alexion receives a warning letter for its Soliris plant in RI, a compounding pharmacy's recall was more extensive than previously disclosed, Pfizer gets a setback in its legal battles over Celebrex, Sun Pharma gets the OK for generic Miraprex, Boston Scientific recalls thousands of ICD leads, FDA approves GE's AndreView, FDA awards a four-year contract for its adverse event reporting system,  and researchers question the value of surrogate outcomes.

Abroad, EMA posts new  procedural guidance on the pharmacovigilance legislation, IQWiG is revising its legal and scientific procedures, Eli Lilly desires more changes to the new CFDA, pediatric drugs are in a huge shortage situation in China, Brazil's black market for steroids is booming, Italy is under fire for allowing an unproven stem cell therapy, and ASEAN adopting a QbD approach for process validation.

Plus: New data show vaccines and vaccine scheduling isn't to blame for Autism, and could hackers really take over your pacemaker?

Five in Focus:

  1. Alexion gets warning letter for Soliris plant (Fierce Pharma Manufacturing)
  2. Pfizer Loses Bid to Have Celebrex Investor Suits Tossed (Bloomberg) (Reuters)
  3. The Number Of Early Childhood Vaccines Not Linked To Autism (NPR) (EurekAlert)
  4. Surrogate Outcomes in Clinical Trials: A Cautionary Tale (JAMA)
  5. Pediatric Drugs In Grave Shortage In China, Only 2% Of Meds (PharmAsia News) ($)


  • Alexion gets warning letter for Soliris plant (Fierce Pharma Manufacturing)
  • Recalled Woburn compounding pharmacy products were shipped to 21 states (Boston Globe)
  • Pfizer Loses Bid to Have Celebrex Investor Suits Tossed (Bloomberg) (Reuters)
  • FDA Approves New ANDA for Sun Pharma's Generic Miraprex (FDA)
  • FDA Approves GE Healthcare's AdreView™ (Iobenguane I 123 Injection) for Cardiac Risk Evaluation in Heart Failure Patients (GE)
  • FDA Presentation: FDA Webinar - Early Alzheimer''s Disease Draft Guidance (FDA)
  • FDA Presentation: Clinical Pharmacology and The Turning Tide of Drug Regulation (FDA)
  • Draft Guidance for Industry: Bioequivalence Recommendations for Metronidazole Vaginal Gel (FDA)
  • J&J set to exploit diabetes drug safety scare (Scrip Intelligence)
  • Rx Response Recognized for Efforts During Hurricane Sandy (PhRMA)
  • Janssen Submits New Drug Application to U.S. FDA for Simeprevir (TMC435) for Combination Treatment of Adult Patients with Genotype 1 Chronic Hepatitis C  (J&J)
  • Administrative Law Trumps the "Immutable Laws of Science," Says the DC Circuit in Challenge Over Generic Derma-Smoothe Approvals; Hill Appeals and Denial Quickly Follows (FDA Law Blog)
  • PDUFA V and Investor Communications (The Pink Sheet Daily) ($)
  • Proposed Collection; 60-day Comment Request: Quantification of Behavioral and Physiological Effects of Drugs Using a Mobile Scalable Device (NIH)
  • Academic White Paper Rebuts FTC and S. 214 (Patent Docs)
Medical Devices
  • Boston Scientific Recalls Thousands of ICD Leads Due to an Error it Says Could Cause the Device not to Function (FDA)
  • FDA Updates Information Page on Urogynecologic Surgical Mesh Implants (FDA)
  • Updated FDA Safety Communication: Stryker Neptune Waste Management Systems (FDA)
  • Materials Posted for Workshop on Color in Medical Imaging (FDA)
  • Biotronik lands CE Mark for MRI-safe Iforia defibrillator (Mass Device)
  • Will another Durata failure report drag St. Jude down? (Mass Device)
  • A mobile health app Sweet 16: Is FDA-approval the ultimate top seed? (Med City News)
  • Agendia took gamble on FDA approval for breast-cancer test (Med City News)
  • FDA Awards Four-Year Contract for Maintenance of Adverse Event Module (FDA)
  • FDA Presentation: How FDA Promotes Partnerships to Accelerate Medical product Development (FDA)
  • FDA Presentation: View from a Regulator: Clinical CAPAs and Their Role in Your Overall Compliance Model (FDA)
  • FDA Wants more Female Rhesus Monkeys for Research (FDA)
  • FDA's Susan Ellenberg: Statistician with a commitment to product safety and efficacy (FDA)
  • Surrogate Outcomes in Clinical Trials: A Cautionary Tale (JAMA)
  • Instructions for Requesting Individual Case Reports on Adverse Events (FDA)
  • CME isn't just for doctors. Big pharma also sponsors training seminars for judges, reports the Center for Public Integrity (CPI)
  • New Utah Legislation Will Require Government Detailers to Face the Same Rules as Industry Ones (Drug Wonks)
  • FDA's International Food Safety Capacity-Building Plan: Improving Food Safety Protections Around the World (FDA Voice)
Government and Budget
Meetings This Week
  • Upcoming FDA Advisory Committee Meetings and Topics (Eye on FDA)
  • 25 March 2013: FDA Webinar on Draft Guidance for Industry on Enrichment Strategies for Clinical Trials to Support Approval of Human Drugs and Biological Products (FDA)
  • 25 March 25: Webinar Draft GFI On Enrichment Strategies For Clinical Trials To Support Approval Of Human Drugs And Biological Products (FDA)
  • 27-28 March 2013: Public Meeting on the Food Safety Modernization Act (FSMA) (FDA)
  • 28 March 2013: Webinar: Draft Guidance For Industry On Alzheimer's Disease: Developing Drugs For The Treatment Of Early Stage Disease (FDA)


  • European Medicines Agency updates procedural guidance in line with new pharmacovigilance legislation (EMA)
  • IQWiG revising legal, scientific procedures (BioCentury)
  • Reflection paper on Immune Tolerance Induction in haemophilia A patients with inhibitors (EMA)
  • Lilly CEO Gives Kudos To China SFDA Reorganization, But Hopes For More (PharmAsia News) ($)
  • Pediatric Drugs In Grave Shortage In China, Only 2% Of Meds (PharmAsia News) ($)
  • ASEAN Adopting QbD Approach to Process Validation Under Singapore Leadership (IPQ)
  • Scientists criticize Italy for allowing unproven stem cell therapy (Reuters)
  • Fake steroid seizures up in Brazil as black market booms (Securing Industry)

General Regulatory and Interesting Articles

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.

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