Regulatory Focus™ > News Articles > Regulatory Reconnaissance (14 June 2013)

Regulatory Reconnaissance (14 June 2013)

Posted 14 June 2013 | By Alexander Gaffney, RAC

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.

In Focus: US

In Focus: International

  • Impatient UK MHRA takes lead on EU device vigilance portal (Clinica)
  • Falsified medicines directive "need not be the enemy of efficiency" (Securing Industry)
  • EU regulator advises caution on painkiller diclofenac (Reuters)
  • The future of HTA harmonisation in Europe (PMLive)
  • China FDA Advises J&J To Clean Up Its Act, Eliminate Recall Conditiions (PharmAsia)
  • EC welcomes list of Indian API suppliers with 'written confirmation' (In-Pharma Technologist)

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  • Xgeva OK'd for Rare Bone Tumor (FDA) (Amgen) (MedPage Today) (DSM) (Pink Sheet) (Pharma Times) (Pharma Letter) (PMLive) (SCRIP)
  • Judge OKs Administration Plan On 'Morning After' Pill (The Order) (KHN)(Reuters) (NBC) (Philly Pharma) (Law 360) (NYTimes) (WSJ)
  • Pfizer starts the Phase I trial of biosimilar Humira (Biosimilar News)
  • FDA: Patient-Focused Drug Development Meeting on Narcolepsy to Occur Around September 2013 (FDA)
  • Is Pharma Excommunication Discouraging Potential Whistleblowers? (In-Pharma Technologist)
  • Survey links quality problems, drug shortages (Modern Healthcare)
  • FDA Sued For Questioning Lupus Product's Label (Law 360)
  • Alexion's Bell Notes The Changing Role Of Innovation In Regulatory Decisions (Pink Sheet)
  • Credit Suisse says Pfizer patent win will discourage 'at-risk' launches (Fierce)
  • FDA Approves ANDAs for Silarx Pharma's Escitalopram Oxalate (#090477) and Fany Care;s Norethindrone (#200980) (FDA)
  • FDA Approves Efficacy Supplements for Amgen's Prolia (BLA #125320), Incyte's Jkafi (NDA #202192) and Amgen's Xgeva (BLA #125320) (FDA)
  • Drug Safety Labeling Changes Made in May 2013 (FDA)
  • Amgen's trebananib meets primary end-point in Ph III study of recurrent ovarian cancer (Pharma Letter)
  • Lilly's experimental rheumatoid arthritis drug effective in mid-stage study (Reuters) (Eli Lilly) (Pharma Times) (SCRIP)
  • Lilly halts Alzheimer's drug trial due to liver problems (Reuters) (Pharma Times) (PMLive) (SCRIP) (Bloomberg)
  • AbbVie Says It Can Be First With New Hepatitis C Drugs (Bloomberg)
  • AARP fears Pfizer tactics to defend Lipitor could become model (Fierce)
  • Public Citizen: NIH Censoring Expert to Prevent Criticism of Ethically Questionable NIH-Funded Study on Premature Infants (PC)
AMP v. Myriad: Case Wrapup
  • As top court invalidates some gene patents, biotech has moved on (Reuters)
  • Opinion recap: No patent on natural gene work (SCOTUS Blog)
  • Myriad Gene Patent Ruling Triggers Race for Cancer Tests (Bloomberg)
  • Patent 'mischief' lurks after Myriad (SCRIP)
  • Industry insiders find reason for optimism and angst in SCOTUS Myriad ruling (MedCity News)
  • High Court's Myriad Ruling Will Spur Novel Patent Claims (Law 360)
  • Supreme Court Gets Decision Right, Science Wrong, on Gene Patents (Forbes)
  • Justice Scalia's Odd Opinion in Myriad (Harvard BOH)
Medical Devices
  • Report identifies 300 medical devices at risk of cyber attacks (Reuters) (Report)
  • FDA Investigators Talk Quality Issues And Inspectional 'Games' Manufacturers Play (Silver Sheet)
  • FDA Safety Communication: Cybersecurity for Medical Devices and Hospital Networks (FDA)
  • FDA's ISO Audit Program Chugs Along; May Be Absorbed By IMDRF Single-Audit Initiative (Silver Sheet)
  • Stryker Escapes FCA Whistleblower Suit Over Pain Pumps (Law 360)
  • With new CEO, funding and FDA clearance, dental implant startup will soft launch in July (Med City News)
  • WellDoc Launchesthe First FDA-Cleared, Mobile Prescription Therapy for Type 2 Diabetes (PharmPro)
Assorted and Government
  • House Appropriations Committee Report Expresses Concerns About FDA; Would Require a Slew of New Action Deadlines (FDA Law Blog)
  • FDA's Hopes For User Fee Un-Sequestration Likely Hinge On Senate Appropriations Panel (Pink Sheet)
  • Striding Towards Greater Access of Clinical Trials Data and Results (FDA Law Blog)
  • Calif. Case Gives FDA Chance To Tackle 'All-Natural' Labels (Law 360)
  • Three Ways for Creating Supplement Advertising that Does NOT Attract FDA and FTC Attention (Natural Products Insider)
  • So, FDA or FTC Has A Problem With Your Product: Now What? (Natural Products Insider)
  • May 2013 Warning Letter Insights for Dietary Supplements (Natural Products Insider)
  • Some Observations from the Howard Shelanski Confirmation Hearing (CPR Blog)
Upcoming Meetings and Events
  • 11-12 June 2013: FDA/NIH/NSF Workshop on Computer Models and Validation for Medical Devices (FDA)
  • 12-13 June 2013: 16th Annual FDA-OCRA Educational Conference (OCRA)
  • 13 June 2013: 510(k) Device Modifications: Deciding When to Submit a 510(k) for a Change to an Existing Device (FDA)
  • 13 June 2013: Good Manufacturing Practice Deficiencies: Federal Health Care Enforcers' Next False Claims Act Target? (WLF)
  • 13 June 2013: Microbiology Devices Panel of the Medical Devices Advisory Committee Meeting Announcement (FDA)
  • 13 June 2013: Markup of FDA Appropriations Bill (House)
  • 14 June 2013: Public Meeting on HIV Patient-Focused Drug Development and HIV Cure Research (FDA)
  • 14 June 2013: Congressional Hearing on Prescription Drug Abuse (E&C)
  • 17 June 2013: FDA Basics Webinar: Biological Products: Part 1 (FDA)
  • 18 June 2013: Understanding the Regulatory Landscape for Adaptive Design Trials (RAPS)
  • 19-20 June 2013: Regulatory Education for Industry (REdI) Conference (FDA)
  • 25-26 June 2013: Standardizing and Evaluating Risk Evaluation and Mitigation Strategies (FDA)
  • 29 June 2013: Clinical Development Programs for Opioid Conversion (FDA)
  • Other Upcoming FDA Advisory Committee Meetings and Topics (FDA)


  • Impatient UK MHRA takes lead on EU device vigilance portal (Clinica)
  • Falsified medicines directive "need not be the enemy of efficiency" (Securing Industry)
  • EU regulator advises caution on painkiller diclofenac (Reuters)
  • France's ANSM probe clears Teva plant in drug switch (Fierce)
  • The future of HTA harmonisation in Europe (PMLive)
  • Annual report of the Good Clinical Practice Inspectors Working Group 2012 (EMA)
  • Verastem wins orphan status from EU for mesothelioma drug (BioFlash)
  • Reverse Medical touts CE Mark in Europe, distribution deal in Japan (Mass Device)
  • Codman Neuro Obtains CE Mark For Enhanced REVIVE SE™ Thrombectomy Device (J&J)


  • China FDA Advises J&J To Clean Up Its Act, Eliminate Recall Conditiions (PharmAsia)
  • EC welcomes list of Indian API suppliers with 'written confirmation' (In-Pharma Technologist)
  • Indian Galvus 'scam' heats up marketing regulation debate (SCRIP)
  • AbbVie and Eisai Announce HUMIRA Has Received Approval for the Treatment of Moderate to Severe Ulcerative Colitis (UC) in Japan (Eisai)
  • ABILIFY® Granted Additional Approval as Adjunctive Therapy for the Treatment of Depression in Japan (Otsuka)
  • Approval of Prograf capsules in Japan for the additional indication of interstitial pneumonia associated with polymyositis /dermatomyositis (Astellas)
  • GSK Says Four-Month Probe Of China Bribe Allegations Finds No Evidence (PharmAsia)
  • China Provinces Pledge To Fight Counterfeit Medicine (PharmAsia)

General Regulatory and Interesting Articles

  • Restoring invisible and abandoned trials: a call for people to publish the findings (BMJ) (MedPage Today) (Science Insider) (MNT)
  • AstraZeneca taps outside experts to screen cancer compounds (Reuters) (Fierce)
  • Two gene variants may predict who will benefit from breast cancer prevention drugs (NIH)
  • High prevalence of NSAID prescription in those at risk of heart attack/death in primary care (EurekAlert)
  • Baldness Drug Curbs Men's Interest in Alcohol, Study Suggests (Yahoo)

Regulatory Reconnaissance #88 - 14 June 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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