Regulatory Focus™ > News Articles > Regulatory Reconnaissance (27 February 2013)

Regulatory Reconnaissance (27 February 2013)

Posted 27 February 2013 | By Alexander Gaffney, RAC

Good morning and welcome to another edition of Regulatory Reconnaissance. Big news out of FDA today: Unlike other agencies, it does not expect to furlough workers, saying it can meet its obligations though cuts in travel, training, contracts and collaborations.

In the US, FDA has halted a clinical trial over the death of a teenager, biosimilar drugs continue to face huge hurdles, Vertex has started a trial for one of its breakthrough designation products, and Medtronic gets approval for an early feasibility study taking a new FDA-recommended approach.

Abroad, UK researchers will be able to use patented drugs in trials, Roche has launched a new clinical data transparency initiative, new EU API import rules are causing headaches and terror, MHRA is looking for a new chief executive, and India wants to price patented drugs based on per capita income.

Five in Focus:

  1. FDA does not anticipate furloughs if automatic budget cuts hit (Philly Pharma)
  2. UK researchers able to use patented drugs in trials (PM Live)
  3. Drug Shortages, Lost Business Chief among Concerns on EU API Import Deadline (In-Pharma Technologist)
  4. Roche launches new process for accessing clinical trial data (Roche) (Pharmalot) (Fierce Biotech) (Reuters)
  5. Biosimilar Drugs Face Uphill Climb to Regulatory Approval (WSJ)



  • FDA does not anticipate furloughs if automatic budget cuts hit (Philly Pharma)
  • FDA, The Sequester & What Good Will? Ira Explains (Pharmalot)
  • AdvaMed fights to keep user fees out of sequester cuts for FDA (Mass Device)
  • OMB, agencies still crunching sequestration-related furlough numbers for non-DoD civilians (Federal News Radio)
  • After the sequester: Why March 27 is even scarier (FCW)
  • Could FDA Avoid Furloughs by Entirely Relying on New FDA User Fees and Leaving Open Positions Unfilled? (GovExec)


  • FDA suspends pediatric clinical trials of Sensipar (cinacalcet hydrochloride) after report of death (FDA)
  • Biosimilar Drugs Face Uphill Climb to Regulatory Approval (WSJ)
  • Merck, Bristol Diabetes Drugs Linked to Pancreatitis Risk (Bloomberg)
  • Vertex plots a race through PhIII for "breakthrough" combo CF therapy (Vertex) (Fierce Biotech)
  • Studies sponsored by industry more likely to report benefits than non-industry studies, less likely to report harms (JAMA)
  • Survey shows medical students have frequent interactions with pharmaceutical companies (EurekAlert)
  • Affymax explores manufacturing for ties to fatal drug reactions (Fierce Pharma Manufacturing)
  • Teva repeats recall after getting batch numbers wrong (Fierce Pharma Manufacturing)
  • New Bioterrorism Vaccine Gets First Test In Humans (Pharmaceutical Online)
  • FDA's Psychopharmacological Drugs AdComm to Meet to Discuss Titan Pharmaceutical's Probuphine subdermal implant (FDA)
  • Oncologic Drugs Advisory Committee to Consider AVEO Pharmaceutical's Advanced Renal Cell Carcino Drug (FDA)
  • What Can Pharmaceutical Companies Expect From the FDA and CMS, the States and Congress? (Pharma Compliance Monitor)

Medical Devices

  • FDA Panel Meeting to Determine Appropriate Classification for Methotrexate Enzyme Immunoassays (FDA)
  • Ophthalmic Devices Panel to Meet to Consider Bausch & Lomb's Trulign Toric posterior chamber intraocular lens (FDA)
  • Medtronic Gains First FDA Approval to Conduct Early Feasibility Medical Device Study (Medtronic)
  • A clinical investigator for Medtronic's CoreValue US Pivotal Trial Has Been Sent a Warning Letter for a Number of Problems, Including Failing to Report Two Deaths for Up to Six Months (FDA)
  • Webcast: Improved Access to Device Information: What a UDI System Can Do for Patients and Consumers (Brookings)
  • Is FDA's Unique Device Identifier Program a Prince Masquerading as a Frog? (MD+DI)

Warning Letters

  • (Pharma) for Unapproved/Misbranded Drugs (FDA)
  • (Pharma) Big Mountain Drugs for Unapproved/Misbranded Drugs (FDA)
  • (IRB) Mark Pinsky for Objectionable Conditions (FDA)
  • (Clinical) Michael Ring for Objectionable Conditions (FDA)
  • (Device) Woo Young Medical for Sterility, Process Validation and Controls (FDA)
  • (Device) Guangdong Biolight Meditech Co. for Adulteration, QSR (FDA)
  • (Supplement)  Kreativ Health Inc. for CGMP Violations (FDA)
  • (Supplement) Capco Custom Packaging for CGMP Violations (for an Infant Product) (FDA)
  • (API) Abbey Color for CGMP, Validation, Water Quality (FDA)


  • Roche launches new process for accessing clinical trial data (Roche) (Pharmalot) (Fierce Biotech) (Reuters)
  • FDA Has Signed a Five-Year, $25 Million Contract With Company to Conduct Straw Purchasing and Monitor Illegal Marketing and Illegal Sales of FDA-Regulated Products Online (FDA)
  • NIH Video Game on Clinical Trials Goes to OMB for Approval (NIH)
  • Disclosure at the Office of Information and Regulatory Affairs: Written Comments and Telephone Records Suspiciously Absent (Center for Effective Government)
  • CVS to pay $650,000 for consumer education after kids got breast cancer drug (Med City News)
  • FDA Changing Time for Its Science Board Meeting (FDA)
  • FDA has a contract out for 8 Female Rheuses Monkeys (FDA)
  • GAO Report Assesses State Approaches to Control Pseudoephedrine (FDA Law Blog)


  • Video: European Parliament Hearing on Medical Device Regulatory Reforms (EP)
  • UK researchers able to use patented drugs in trials (PM Live)
  • MHRA looking to appoint new Chief Executive (MHRA)
  • Drug Shortages, Lost Business Chief among Concerns on EU API Import Deadline (In-Pharma Technologist)
  • UK study confirms GSK flu shot link to rare sleep disorder (Reuters)
  • MHRA's Annual Report on the Regulation of Medicines Advertising (MHRA)
  • NICE recommends BMS-Pfizer's Eliquis to prevent stroke (PM Live) (Pharma Times)
  • Anika Therapeutics S.r.l. withdraws its marketing authorisation application for Hyalograft C autograft (EMA)
  • Device makers, regulators butt heads over new E.U. regulations (Mass Device)
  • Indian Government panel proposes to regulate prices of patented medicines (Economic Times of India) (2)
  • Summary of Meeting Between Canadian Regulators and the Generic Pharmaceutical Industry of Canada (Health Canada)
  • GlobalData: New Zealand focuses on generics (Biospectrum)


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.

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