Regulatory Focus™ > News Articles > Regulatory Reconnaissance (20 March 2013)

Regulatory Reconnaissance (20 March 2013)

Posted 20 March 2013 | By Alexander Gaffney, RAC

Good morning and welcome to another edition of Regulatory Reconnaissance.

In the US, FDA reviewers pan Titan's drug application and reject Pharmaxis' CF drug application, Star Scientific gets a subpoena, Sanofi encounters manufacturing delays, a recall of Omontys has left Affymax in fiscal ruin, FDA continues to fine-tune its UDI rule, FDA says poor training to blame for Stryker device deaths, Congress continues a multi-day hearing about mobile health regulations, and FDA posts a new batch of warning letters.

Abroad, India finds its regional regulators approved at least 23 drugs without permission, a prominent UK group is pushing for data transparency, MHRA defends its regulation of preclinical research after a case of fraud, India's CDSCO creates a panel to investigate clinical trials deaths, Health Canada modifies the requirements for submitting NOCs, and India's overhaul of its drug regulatory system is still months away.

Five in Focus:

  1. FDA reviewers say Titan drug dose may be insufficient (Reuters) (Fierce Biotech) (Med Page Today)
  2. FDA turns down Pharmaxis cystic fibrosis drug (Pharma Times) (Pink Sheet Daily) ($)
  3. FDA Fine-Tuning UDI Final Rule, OTC Exemption May Be Dropped (FDA News) ($)
  4. Centre finds SLAs granted 23 licenses for FDCs without DCGI approval (PharmaBiz)
  5. India Fast-Tracking Drug Regulation Overhaul, But Still Months Away (Pharm Asia News) ($)


  • FDA reviewers say Titan drug dose may be insufficient (Reuters) (Fierce Biotech) (Med Page Today)
  • FDA turns down Pharmaxis cystic fibrosis drug (Pharma Times) (Pink Sheet Daily) ($)
  • Star Scientific Subpoenaed by U.S. Attorney's Office (The Street)
  • Knee trial for Merck KGaA (Pharmafile)
  • Ruling on Generic Pre-Emption Case Expected in Summer 2013 (The Hill)
  • Biosimilars: Not So Far So Fast (GEN)
  • The Best Prescription for Pre-Emption: Would you rather have a jury or medical experts judge drug safety? (WSJ)
  • Sanofi Manufacturing 'Delays' Cause Shortage of TB Drug (In-Pharma Technologist)
  • Biogen receives patent until 2028 for Multiple Sclerosis drug Tecfidera (Reuters)
  • Affymax in a tailspin after Omontys recall (PM Live)
  • Amgen's melanoma drug shows promise in key trial (Reuters)
  • High Potency Statins Linked To Increased Risk For Acute Kidney Injury (Forbes)
  • Compounding Pharmacy Crackdown Continues With Avastin Recall (Medscape News)
  • IPO Files Amicus Brief in Support of Respondents in AMP v. Myriad Genetics (Patent Docs)
  • Second Circuit Comes to a Split Decision on Standing in NRDC Lawsuit Over OTC Triclosan and Triclocarban Products (FDA Law Blog)
Medical Devices
  • FDA Fine-Tuning UDI Final Rule, OTC Exemption May Be Dropped (FDA News) ($)
  • FDA blames poor training for new deaths, injuries tied to Stryker's recalled Neptune systems (Mass Device)
  • Allergan lands a date with the FDA (Mass Device) (FDA)
  • Live blog: Does the medical device tax apply to my iPhone and iTriage app? (Med City News) (MobiHealth News)
  • Committee Kicks Off Three Day Hearing Series On Potential Regulations and Taxes on Smartphones, Tablets, and Mobile Apps (Congress) (mHealth Regulatory Coalition)
  • Mobile health app hearings Day 1: 5 talking points that underscored the regulatory debate (Med City News)
  • Simulation proves essential to FDA evaluations (Medical Design)
  • Lantos 3D Scanner for Imaging Ear Canal Approved by FDA (Med Gadget)
  • OptosOCT SLO Combines Microperimetry with OCT, Cleared by FDA (MedGadget)
  • Unique Device Identification (UDI) Implementation Expert Workshop #3 (Brookings)
  • Medtech's 'Wild West': Mobile Health Applications (Medical Design)
  • FDA Makes Editorial Changes to Advisory Committee Regulation (FDA)
  • 2012 End-of-Year Summary of Promotional Enforcement Activity (Covington)
  • Bill on Dangerous Drug Disposal by Pharmacists Seems Likely in new Mexico (Scout)
  • Current trends in the FDA's enforcement of GMP requirements (Lexology)
  • President's Bioethics Commission Posts Data on Federally Supported Research Involving Human Volunteers (PCSBI)
  • Nurse spotted mold-tainted drugs right away, hospital says (NBC)
  • GAO pushes FDA for final NDI guidance to improve enforcement efforts (Drug Store News)
  • FDA should take action to help consumers find out the true cost of medicines, Paper says (LATimes)
  • H.R.1239 - To amend part D of title XVIII of the Social Security Act to count the negotiated price of drugs provided free or at nominal charge under compassionate treatment programs towards incurred out-of-pocket costs (Congress)
  • Government quits legal battle over graphic cigarette warnings (Washington Post)
  • Wyden seeking list of drugs based on NIH research (BioCentury)
Government and Budget
  • Inside Washington's Regulatory Sausage-Making Process (Washington Monthly)
  • Reid schedules votes to advance the CR as it slowly moves toward final passage (The Hill)
  • House budget debate solves nothing, but sets up Wednesday votes (The Hill)
Warning Letters
  • (Medical Device) Stryker Instruments for MDR, Device Validation, Preliminary Hazard Analysis, CAPA, Misbranding, Adulteration (FDA)
  • (Medical Device) Continental Medical Labs for CGMP, QSR, CAPA Regulation Deficiencies (FDA)
  • (Medical Device) Neusciences PR for CGMP, CAPA, Stability Testing, QSR, Long List of Failures (FDA)
  • (Medical Device) Atossa Genetics for Unapproved Devices, CGMP, QSR (FDA)
  • (Medical Device) Kral X-Ray for Not Complying With X-Ray Regulations on Installation of Devices (FDA)
  • (Dietary Supplement) Healthwest Minerals for Supplement CGMP Deficiencies (FDA)
Meetings This Week
  • March 20, 2013: Circulatory System Devices Panel of the Medical Devices Advisory Committee Meeting Announcement (FDA) (Meeting Materials)
  • March 21, 2013: Meeting of the Psychopharmacologic Drugs Advisory Committee Meeting Announcement (FDA)
  • March 22, 2013: FDA Public Workshop: Innovations in Breast Cancer Drug Development - Neoadjuvant Breast Cancer Workshop (FDA)
  • March 19th, 2013: FDA Webinar: Buyer Beware: The Risks and Dangers of Purchasing Drugs Online (FDA)


  • Centre finds SLAs granted 23 licenses for FDCs without DCGI approval (PharmaBiz)
  • Wellcome pushes for release of drug results (FT)
  • Preclinical Data Fraud is 'Rare' says UK MHRA and Rule Rejig Not Needed (Outsourcing Pharma)
  • India Fast-Tracking Drug Regulation Overhaul, But Still Months Away (Pharm Asia News) ($)
  • India's CDSCO Creates Expert Panel to Examine Clinical Trials Deaths (CDSCO)
  • Health Canada Intends to Modify Content of NOCs for Administrative Submissions (Health Canada)
  • Drug Controller General of India to inspect bulk drug plants exporting to EU (Economic Times) (PharmAsia News) ($)
  • Maharashtra FDA cracks down on wholesalers for illegal diversion of 'Codeine' (Economic Times)
  • GW Pharma says German Sativex pricing "unacceptable" (PM Live)
  • Bayer's Eylea data 'unreliable', says IQWiG (PM Live)
  • European Union Drugs Strategy 2013-2020 (EU)
  • EMA's Reflection on eTMF (Clinical Trials Online)
  • MPs Hear Why Clinical Trials Are Off-Putting To Researchers And Patients (Eye for Pharma)
  • Knee Implant GelrinC Receives European CE Mark Approval (Medical News Today)
  • New Australian pharmaceutical code increases reporting - with more to come (Clifford Chance)
  • Australia: Review of the arrangements for the scheduling of medicines and poisons (TGA)
  • EU Proposal for a Regulation on Medical Devices: impact on the perceived European advantage in marketing novel devices (Lexology)

General Regulatory and Interesting Articles

  • Under Pressure: Implantable Gel Releases Drugs When Squeezed (MedGadget)
  • Fighting a Global War on Rare Diseases (Xconomy)
  • Filters often used to stop clots without evidence (Reuters)
  • Hip implant patients with unexplained pain likely to have tissue damage (EurekAlert)

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 or @AlecGaffney 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.

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