Regulatory Focus™ > News Articles > Regulatory Reconnaissance (8 March 2013)

Regulatory Reconnaissance (8 March 2013)

Posted 08 March 2013 | By Alexander Gaffney, RAC

Good morning and welcome to another edition of Regulatory Reconnaissance. Margaret Hamburg confirms the agency is unable to spend any of the increased funding it got under FDASIA, which could put the biosimilar program in jeopardy.

In the US, Reuters think problems with a vaccine adjuvant could pose problems for FDA and GSK, a cancer group calls on FDA to fast-track smoking cessation drugs, whistleblowers are opening up about an infamous pharmaceutical compounder, one of Dr. Reddy's drugs is being recalled due to a 'strong garlic odor,' a lawyer says a recent Untitled Letter sent by FDA is actually a Warning Letter, J&J recalls KY Jelly because it doesn't have a cleared 510(k), a protest is planned for FDA's College Park campus, and a lawsuit has raised question regarding whether GE tried to hide the risks of a MRI dye.

Abroad, India's DCGI says he's working on changes to India's drug regulatory system, New Zealand will fund unapproved medicines for various conditions, legislators propose changes to a draft clinical trials proposal, an EU researcher says clinical trials don't have enough of a gender balance, and a UK legislator argued 'value-based pricing' talk is nothing but buzzwords.

Five in Focus:

  1. Biosimilars program at risk due to lack of user fee spending authority, Hamburg says (BioCentury) (Regulatory Focus)
  2. Simplified single window clearances for all drug licenses necessary: DCGI (PharmaBiz)
  3. Honey, Pass The… Uh-Oh, J&J Recalls K-Y Jelly, Needs to Re-Submit 510(k) (Pharmalot) (FDA) (FDA) (FDA)
  4. 'Burn the Data': Did GE Try to Hide Risks of MRI Dye Omniscan? (ProPublica)
  5. Narcolepsy link to Glaxo vaccine poses challenge for FDA (Reuters)


Sequester & Budget

  • Biosimilars program at risk due to lack of user fee spending authority, Hamburg says (BioCentury) (Regulatory Focus)
  • Narcolepsy link to Glaxo vaccine poses challenge for FDA (Reuters)
  • Ranbaxy stamps out legal move to expand recall (Fierce Pharma Manufacturing)
  • Finnish Drugmaker Gets Form 483 for 'Contaminated' Plant Corridors (FDA News) ($)
  • Generic Companies Ask Court for Access to Actelion Drugs, Accuse Brand of Anticompetitive Behavior (FDA News) ($)
  • ASBM Chairman: Patient Safety Key to Creating Global Biosimilar Standards (ASBM)
  • American Cancer Society: We Support Use of Fast-Track Status for Smoking Cessation products (Federal Register)
  • New Superiority Trial Showed LIVALO® (pitavastatin) 4 mg Provided Significantly Greater LDL-C Reduction in HIV-Infected Adults with Dyslipidemia versus Pravastatin 40 mg (Eli Lilly)
  • Whistleblower Talks to CBS About Pharmaceutical Compounding Crisis (CBS)
  • Delcath's Melblez Chemosaturation System To Face ODAC Scrutiny (The Pink Sheet Daily)
  • Dr. Reddy's Laboratories Drug Recalled Due to "Strong Garlic Odor" (FDA)
  • Biogen Asked in Suit to Return ALS Biosamples to Knopp (Bloomberg)

Medical Devices
  • 'Burn the Data': Did GE Try to Hide Risks of MRI Dye Omniscan? (ProPublica)
  • HPM Lawyer: FDA's "Untitled Letter" Email to Contact Lens Manufacturers A Warning Letter in Disguise (FDA Law Blog)
  • Honey, Pass The… Uh-Oh, J&J Recalls K-Y Jelly, Needs to Re-Submit 510(k) (Pharmalot) (FDA) (FDA) (FDA)
  • Philips Recalls Numerous Devices Over Software Problems (FDA) (2) (3) (4)
  • 3D Printing Device That Can Print New Skulls Gets 510(k) Clearance by Way of FDA (MedGadget)
  • Renal denervation: Medtronic reaches for broader patient population (Fierce Medical Devices)
  • FDA considers patent extension for Edwards' Sapien TAVI heart implant (Mass Device)
  • EpicGenetics rolls out first fibromyalgia-specific blood Dx (Fierce Medical Devices)
  • LifeScan Receives FDA clearance for OneTouch VerioSync Bluetooth Blood Glucose Meter (MedGadget)
  • SYNERGY Blood Pump from CircuLite Gets IDE Approval to Begin Clinical Trial (MedGadget)
  • Class 1 Recall: Ad-Tech Medical Instrument Corporation, Macro Micro Subdural Electrodes (FDA)
  • Statistical Tinkering in Device Regulation a Disservice to Patients (BioWorld)
  • Medtronic Submits IDE to FDA for U.S. Randomized Clinical Trial for Uncontrolled Hypertension Patients with Systolic Blood Pressure Between 140-160 mm Hg (Medtronic)

  • Protest Planned at FDA's College Park, MD Campus (PR Newswire)
  • A bill to amend the Federal Food, Drug, and Cosmetic Act to ensure that valid generic drugs may enter the market (Congress)
  • Updated: FDA Solicitation for Advanced Research and Development of Regulatory Science and Innovation (FedBizOpps)
  • Public Webinar : Office of Health Assessment and Translation Webinar on the Assessment of Data Quality in Animal Studies (NIH)
  • GMP compliance is a 'huge opportunity' for dietary supplements market: Chromadex CEO (Nutra Ingredients USA)
  • Medicare Drug Committees Lack COI Oversight (Pharmalot)
  • Six months after fungal meningitis outbreak, patients still get infections (NBC)
  • Public Webinar: Report on Carcinogens Webinar on Pentachlorophenol (NIH)
  • Gift study shows med students still being comped (MM&M)


  • China to further regulate stem cell clinical experiments (Shanghai Daily)
  • Simplified single window clearances for all drug licenses necessary: DCGI (PharmaBiz)
  • India's CDSCO issues comprehensive list of FDCs approved by DCGI since 1961 till Feb, 2013 (PharmaBiz) (List)
  • India Issues Revised Draft Guidelines for Issue of Written Confirmation Certificate for Export of API to the EU (CDSCO)
  • New Zealand to fund unapproved medicines for "various conditions" (PHARMAC)
  • EU Health experts urge greater gender balance in clinical trials (EuroActiv) (2)
  • EMA opens debate on pig products in vaccines (Fierce Vaccines)
  • ENVI Amendments to Clinical Trials Overhaul Legislation (1) (2) (3)
  • Human Medicines Highlights: Issue 49 (EMA)
  • European Patent Filings Up, But Pharma Stays Flat (PharmTech)
  • Updated: Questions & Answers: Positions on specific questions addressed to the pharmacokinetics working party (EMA)
  • Janssen Submits European Marketing Authorisation Application for Canagliflozin/Metformin Fixed-Dose Combination Therapy to Treat Patients with Type 2 Diabetes (J&J)
  • Germany seeks to prevent AMNOG assessment suits (BioCentury)
  • Value-based pricing 'smoke and mirrors' says GP leader (Pharma Times)
  • Takeda files bowel drug vedolizumab in Europe (Pharma Times)


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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