Regulatory Focus™ > News Articles > Regulatory Reconnaissance (3 April 2013)

Regulatory Reconnaissance (3 April 2013)

Posted 03 April 2013 | By Alexander Gaffney, RAC

Good morning and welcome to another edition of Regulatory Reconnaissance.

In the US, Massachusetts and Maryland are both contemplating new rules for compounding pharmacies, the US Trade Representative is mulling a response to India's patent ruling on Glivec and has released a trade agreement for comment, a new regulatory science program has its first meeting, Medtronic gets a 510(k) clearance for its new xxygenation system, Sarepta eyes approval for its muscular dystrophy drug, Aurobindo Pharma gets a tentative nod from FDA for an anti-AIDS drug, FDA is skeptical about Cysview, a Chinese man is accused of stealing cancer data, Congress gets ready to look at re-authorizing animal drug user fee acts, and a new study looks at FDA's treatment of social media.

Abroad, Canadian cancer patients got weak doses of chemo drugs, NICE is still developing methodologies to assess orphan drugs, India's proposed clinical trial rules are panned, Merck sues Glenmark in India to protect Januvia, a new OECD report looks at the use of clinical data, the UN wants more pharmaceutical manufacturing to be done in Africa, IQWiG backs Eliquis for new indications, and TGA and MHRA issue warnings about an intraocular lens.

Five in Focus

  1. US Trade Representative Calls for Comments on Proposed Transatlantic Trade and Investment Agreement (USTR)
  2. Mass. weighs new rules for compounding pharmacies (Boston Globe)
  3. NICE still developing Orphan drug methodology (BioCentury) (PMLive)
  4. Hearing Scheduled on the Reauthorization of Animal Drug User Fees: ADUFA and AGDUFA (E&C)
  5. The Next Glivec? Merck Sues Glenmark In Bid To Protect Januvia From Indian Generics (PharmAsia News) ($) (Economic Times) (Pharma Times) (SCRIP Intelligence)


  • Mass. weighs new rules for compounding pharmacies (Boston Globe)
  • USTR Mulls Response To India SC's Glivec Ruling, Pfizer Wants WTO Look (PharmAsia News) ($)
  • Novavax vaccine meets mid-stage trial goal, shares rise (Reuters)
  • New-look Sarepta eyes approval for muscular dystrophy drug (Reuters)
  • Aurobindo Pharma gets tentative nod from FDA for Anti-AIDS drug (Economic Times)
  • Cysview's Safety Information Not Pretty In Pink, FDA Tells Photocure (The Pink Sheet Daily) ($)
  • Pharma Waste Having an Unknown Impact on Aquatic Life and Water Quality (Med India)
  • Ampio's Eye Drug Trial Design Won't Pass FDA Muster (The Street)
  • Actavis Launches Pulmicort Respules Generic On Heels Of Patent Victory (The Pink Sheet Daily) ($)
  • Eli Lilly insurer's lawsuit says insider information led to $60 million drug heist (Med City Indiana)
  • Analysis: No quick fix in sight for AstraZeneca's PhIII woes (Fierce Biotech)
  • Discord Among Accord and Acorda Over AMPYRA Biostudy Sample Leads to Restricted Distribution Antitrust Lawsuit (FDA Law Blog)
  • Maryland Proposes New Law to Regulate Practice of Sterile Compounding (Scout)
  • Citizen Petition to Reconsider and Revoke the Orphan Drug Designation Granted to GeNO on June 18, 2012 for Nitric Oxide (FDA Docket)
  • Just how 'encouraging' is BioCryst's FDA letter? (Triangle Business Journal)
  • New Animal Drugs; Enrofloxacin; Tilmicosin; Tylosin (FDA)
Medical Devices
  • Private-Public Partnership between FDA and Device Industry Kicks Off Inaugural Meeting (MDDI)
  • Medtronic Announces FDA Clearance and First Uses of New Oxygenation System for Adult Cardiac Surgery (Medtronic) (Mass Device)
  • Abiomed kicks off FDA-targeted trial for new Impella (Fierce Medical Devices)
  • BioMaterials Access Assurance Act Case Raises Novel Device Questions (Drug and Device Law)
  • Medical device recalls for March 2013 (Mass Device)
  • Sandia NL Developing Biothreat Detector for Clinical Use (Med Gadget)
  •  Kentucky cardiologist invokes wartime statute in Medicare kickbacks case (Mass Device)
  • Comment Request: Information To Accompany Humanitarian Device Exemption Applications and Annual Distribution Number Reporting Requirements (FDA)
  • CDC Wants to Re-Instate its  Survey of Rapid Influenza Diagnostic Test (RIDT) Practices in Clinical Laboratories (CDC)
  • US Trade Representative Calls for Comments on Proposed Transatlantic Trade and Investment Agreement (USTR)
  • US holds back on pharma IP in Asia-Pacific trade talks (Pharma Times)
  • Nobel Scientist: White House brain project among most ambitious (CBS) (SCRIP Intelligence)
  • Feds: Man Stole US Cancer Data to Study in China (ABC) (JSOnline)
  • Social Media Does Not Incur FDA Wrath, After All (Pharmalot) (Eye on FDA) (Study)
  • Many Docs & Researchers Know Little About The Sunshine Rule (Pharmalot)
  • Call for Collaborating Partners for National Women's Health Week (DHHS)
  • Rx Response reporting system gets name change (Drug Store News)
  • Indiana Proposes New Blood Donation Testing Standards (Scout)
Government and Budget
  • Hearing Scheduled on the Reauthorization of Animal Drug User Fees: ADUFA and AGDUFA (E&C)
  • Budget cuts push conferences online (Federal Times)
  • Obama nominates economic aide as OMB deputy director (Federal Times)
  • Obama expected to propose 1% raise for 2014 (Federal Times)
  • Reminder: President's FY2014 Budget Due out Around 8-10 April 2013
Meetings and Events This Week
  • 4 April 2013: Hamburg to Deliver Keynote to 2013 National Rx Drug Abuse Summit (NRxDA Summit)
  • 4 April 2013: NIH's Francis Collins to Appear on Stephen Colbert's 'The Colbert Report' (Colbert Nation)
  • 5 April 2013: Orthopaedic and Rehabilitation Devices Panel of the Medical Devices Advisory Committee Meeting Announcement (FDA)
  • 8 April 2013: Ophthalmic Devices Panel of the Medical Devices Advisory Committee Meeting Announcement (FDA)
  • 25 April 2013: Clinical Chemistry and Clinical Toxicology Devices Panel of the Medical Devices Advisory Shortened to a Single Day (FDA)
  • Other Upcoming FDA Advisory Committee Meetings and Topics (Eye on FDA)


  • Cancer patients in Canada got weak doses of chemo drugs (CNN)
  • NICE still developing Orphan drug methodology (BioCentury) (PMLive)
  • Changes to Indian Clinical Trial Compensation Rules Expected (Outsourcing Pharma)
  • The Next Glivec? Merck Sues Glenmark In Bid To Protect Januvia From Indian Generics (PharmAsia News) ($) (Economic Times) (Pharma Times) (SCRIP Intelligence)
  • Drugs for Indian Poor Spark Pfizer Anger at Lost Patents (Bloomberg)
  • Analysis: Big Pharma down, not out, after Indian patent blow (Reuters)
  • OECD Report on Balancing Health Privacy Rights and Using Data to Advance Care (OECD)
  • UNAIDS calls for investment in local African pharma production (PharmAfrica)
  • Apollo Endosurgery wins first EU approval (Fierce Medical Devices)
  • EMA Updates Requirements for Submitting PIPs (FDA News) ($)
  • Japan To Rule On Iressa Responsibility For Deaths, Government Cleared (PharmAsia News) ($)
  • Innovative treatment for canine epilepsy: European approval granted for Boehringer Ingelheim's Pexion (BI)
  • IQWiG backs Eliquis for additional indication (BioCentury)
  • GSK announces first four-strain seasonal influenza vaccine granted marketing authorisation in Germany and the UK (GSK)
  • Canadian Draft Guidance on Disinfectant Drugs (Health Canada)
  • CFDA Revises Instructions Of Compound Qingdai Pill, Tablet, Capsule (PharmAsia News) ($)
  • TGA, MHRA Facilitate Recall of Hoya Intraocular Lenses Due to Higher Than Expected Rates of Inflammation and Endophthalmitis (TGA) (MHRA)

General Regulatory and Interesting Articles

  • If You Can 3-D Print a Gun, Why Not a Medical Device? (MDDI)
  • Myths In The Pricing Of New Drugs (Forbes)
  • Do Federal Regulations Impede Economic Growth? (RegBlog)

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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