Regulatory Reconnaissance (9 April 2013)

Posted 09 April 2013 | By Alexander Gaffney, RAC 

Good morning and welcome to another edition of Regulatory Reconnaissance.

In the US, Bausch + Lomb gets FDA approval for its Prolensa NDA and a nod for its eye implant for an AdComm, Warner Chilcott is facing a lawsuit over Loestrin pay-for-delay deals, Gilead seeks US approval for sofobuvir, Janssen gets FDA approval to release lots of its Doxil drug made under special conditions, FDA releases six new bioequivalence standards, FDA clears an iPhone vision test, medical device funding is being hit by regulatory concerns, OIG updates its civil monetary penalties for false claims, next week's Myriad case could strike down human gene patents, protesters march on FDA, FDA's BIMO and CLIIL databases get a quarterly update, and FDA releases a lengthy missive on the safety of vaccines.

Abroad, many countries look unlikely to meet new EU API rules, UK doctors are urging all patients to have defective PIP breast implants removed, SCRIP takes a look at Anvisa's new authority to veto patents, India's patent practices called inconsistent, India defends its rejection of a Novartis patent, China expands its essential drug list, and a Korean-US FDA workshop looks at drug regulation and marketing.

Plus: Are biosimilars a confidentiality nightmare for contracted groups?

Five in Focus

  1. India, China Fall Behind in Preparation for New EU API Rules (Outsourcing Pharma)
  2. Bausch + Lomb wins FDA panel nod for eye implant (Fierce Medical Devices) (Reuters) (Mass Device)
  3. Janssen Releases Additional Doxil Lot via Alternative Manufacturing Approach (Outsourcing Pharma)
  4. High Court Case Could Strike Down Human Gene Patents (Law 360) ($)
  5. President Barack Obama's FY2014 Budget out Tomorrow


  • FDA Releases Six New Bioequivalence Guidelines (FDA)
  • Plan B's fallout (BioCentury) ($)
  • A State Bill Over Drug Shortages Opens A Compounding Loophole (Pharmalot)
  • FDA Extends Cancer System Review (Drug Discovery and Development)
  • InVivo Therapeutics Receives Approval From FDA For First Human Trial Using Biomaterials For Traumatic Spinal Cord Injury (Medical News Today)
  • Warner Chilcott Sued Over Loestrin Pay-For-Delay Deals (Law 360) ($)
  • Sarepta-Glaxo Duchenne's Rivalry Heats Up This Week (The Street)
  • Gilead seeks US approval of sofosbuvir in HCV (Biocentury) (Fierce Biotech) (SCRIP Intelligence) ($)
  • US FDA sets new PDUFA action date for Vifor's Injectafer NDA (The Pharma Letter)
  • Janssen Releases Additional Doxil Lot via Alternative Manufacturing Approach (Outsourcing Pharma)
  • New Animal Drugs: 43 Changes of Sponsor (FDA)
  • Collaborations in Translational Research Speed the Drug Pipeline (Laboratory Equipemt)
  • Eisai Discontinuing Prodrug Version of Propofol (FDA)
  • Urgent Field Safety Notice (10699578) OpenGene DNA Sequencing System MicroCel 500 and MicroCel 300 Buffer Chamber Possible Hazard (FDA)
  • Veterinary Oversight of Antimicrobial Use in Livestock; Public Meetings Agenda (FDA) (Agenda)
  • CVM Public Master Files (PMFs) in development (FDA)
  • New ANDAs for Kudco Ireland (Generic Lipitor) and Hospira (Zoledronic Acid) (FDA)
Medical Devices
  • Bausch + Lomb wins FDA panel nod for eye implant (Fierce Medical Devices) (Reuters) (Mass Device)
  • Bausch & Lomb Receives FDA Approval for PROLENSA (BioSpace)
  • FDA clears iPhone vision test (Mobi Health News)
  • Stryker Hip Implant Litigation In NJ Heads To Mediation (Law 360) ($)
  • CareFusion hit by another warning for its Alaris infusion pump (Mass Device)
  • Medtech funding shifts to new sources; unstable regulatory environment shares the blame (Medical Design)
  • Robot Hot Among Surgeons but FDA Taking a New Look (AP)
  • GE launches cancer assay with eye on companion Dx (Fierce Medical Devices)
  • Allied Healthcare Group seeks 510(k) for its heart tissue patch (Mass Device)
  • Public Meeting - FDA/NIH/NSF Workshop on Computer Models and Validation for Medical Devices, June 11-12, 2013 (FDA)
  • Orthopaedic and Rehabilitation Devices Panel of the Medical Devices Advisory Committee (FDA)
  • DHHS' OIG Updates its Civil Monetary Penalties for False Claims (OIG)
  • High Court Case Could Strike Down Human Gene Patents (Law 360) ($)
  • More Mobile Health App Guidance from FDA for Pharma to Worry About (Pharma Marketing Blog)
  • FDA's Margaret Hamburg named to "Top 25 Women in Healthcare" List (Modern Healthcare)
  • Protesters demonstrate at FDA against GMOs (ABC7)
  • FDA Updates BIMO, CLIIL Databases (FDA) (FDA)
  • Consumer Concepts Issues a Voluntary Nationwide Recall of ROCK-IT MAN All Natural Male Supplement Products Marketed as Dietary Supplements to Support Male Sexual Performance Due to Undeclared Active Ingredient (FDA)
  • Major counterfeit drugs haul in US (Securing Industry)
  • Novartis, Venter Institute Collaborate on New H7N9 Vaccine with CDC (Outsourcing Pharma)
  • FDA's Changing Culture: What Every Food Company Needs to Know (Food Safety Magazine)
  • Administration pushes toward electronic medical records (The Hill)
  • HHS to combine licensure-tracking databases (Fierce Health IT)
  • 2 Rhode Island Men Plead Guilty In International Fake Internet Pharmacy Scheme (Safe Medicines)
  • Submission for OMB Review; 30-day Comment Request: The Clinical Trials Reporting Program (CTRP) Database (NCI) (NIH)
  • A Parents' Guide to Kids' Vaccines (FDA)
Government and Budget
  • Medical device lobbying chiefs rally in defense of medtech tax repeal (Mass Device)
  • Researchers urged to get 'militant' in seeking sequester reversal (SCRIP Intelligence)
  • A budget primer for White House budget week (Washington Post)
  • International Services Agreement Trade Talks Move Forward (Senate)
  • H.R.845 - Saving High-Tech Innovators from Egregious Legal Disputes Act of 2013 (Congress)
  • H.R.698 - HIV Organ Policy Equity Act (Congress)
  • H.R.672 - Prescription Drug Abuse Prevention and Treatment Act of 2013 (Congress)
  • Reminder: President's FY2014 Budget Due on 10 April 2013
Meetings and Events This Week
  • 8 April 2013: Ophthalmic Devices Panel of the Medical Devices Advisory Committee Meeting Announcement (FDA) (Meeting Materials)
  • 9 April 2013: Congressional Hearing: Reauthorization of Animal Drug User Fees: ADUFA and AGDUFA (E&C)
  • 10 April 2013: Public Workshop: Application of Advances in Nucleic Acid and Protein Based Detection (FDA)
  • 11 April 2013: Device Good Manufacturing Practice Advisory Committee Meeting Announcement (FDA) (Meeting Materials)
  • 17 April 2013: Cellular, Tissue and Gene Therapies Advisory Committee Meeting (FDA)
  • Other Upcoming FDA Advisory Committee Meetings and Topics (Eye on FDA)


  • India, China Fall Behind in Preparation for New EU API Rules (Outsourcing Pharma)
  • U.K. doctors urge removal of all PIP breast implants (Fierce Medical Devices)
  • Health ministry to finalise guidelines to be followed by API units before exporting to EU (PharmaBiz)
  • If FDA could veto patents … Brazil shows how that might work (SCRIP Intelligence) ($)
  • Benefit Analysis Reqs Are More Work but Revised PSURs Are Better says EFPIA (Outsourcing Pharma)
  • South Korean medical device approvals up 7% in 2012 (Mass Device)
  • India's Solution To Drug Costs: Ignore Patents And Control Prices - Except For Home Grown Drugs (Forbes) (Drug Wonks)
  • EMA Revises Guidelines for Submitting Labeling Examples for Approval (FDA News) ($)
  • India defends rejection of Novartis patent bid (Economic Times)
  • Amgen Ends Hiatus, Returns To Japan Market With Three Biotech Drugs (PharmAsia News) ($)
  • Australia's TGA Urges Added Caution For Pediatric Singulair Asthma Drug (PharmAsia News) ($)
  • Germany's IQWiG Approves Eliquis For AF, But Restricts Its Indication (EuroPharma Today)
  • Human Medicines Highlights for EMA: Issue 50 (EMA)
  • Experts urge Australia to act on pharma IP, clinical trials (Pharma Times)
  • China expands Essential Drug List (BioCentury)
  • First Korean-U.S. Workshop on Drug Regulation and Marketing (FDA News) ($)

General Regulatory and Interesting Articles

  • Are Biosimilars a Confidentiality Nightmare? (Outsourcing Pharma)
  • Corporate Reputation of Pharma in Germany, Italy, UK and USA (PR) (Fierce Pharma)
  • New PCR Chip for Automatic Single-Nucleotide Polymorphisms (MedGadget)
  • Regulatory Protectionism: A Hidden Threat to Free Trade (CATO)
  • Industry Viewpoint: What it takes to ensure a quality process (Medical Design)
  • Debunking a myth: IUDs proven safe birth control for teenagers (EurekAlert)
  • The wild story behind a promising experimental cancer drug (AEI)

Regulatory Reconnaissance #41 - 9 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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