Regulatory Focus™ > News Articles > Regulatory Reconnaissance: Novartis Accused of Filing Fake Regulatory Documents (5 March 2014)

Regulatory Reconnaissance: Novartis Accused of Filing Fake Regulatory Documents (5 March 2014)

Posted 05 March 2014 | By Alexander Gaffney, RAC

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In Focus: US

  • Biosimilars in 2014: An Interview With FDA New Drugs Head John Jenkins (RPM Report-$)
  • OIG Digs Deep For Individual Responsibility at Endo (RPM Report-$)
  • 4 Deaths Linked To Thoratec Heart System (Forbes) (WSJ-$) (FDA) (Bloomberg)
  • Medtronic Sued by 1,000 Infuse Patients (MedPage Today)
  • FDA Custom Device Exemption Still Won't See Much Use (Law 360-$)
  • Study examines gap in federal oversight of clinical trials (MNT)
  • FDA Launches New Webpages, Twitter Account (FDA) (Twitter) (FDA)

In Focus: International

  • Novartis may be fined for submitting 'fake' document to Drug Controller General of India (India Times)
  • EMA finalizes guidance on process validation for manufacturers (In-Pharma)
  • Print adverts' prescribing info could be axed in UK (Pharmafile)
  • Adjusted EMA Fees Come Into Effect on 1 April 2014 (EMA)
  • Takeda Japan candesartan promotion, study under scrutiny (SCRIP-$) (WSJ-$) (Fierce)
  • Russia Threatens to Seize Companies-Such as Pharmaceutical Companies-if EU, US Levy Sanctions (CNN)

US: Pharmaceuticals/Biotechnology

  • Biosimilars in 2014: An Interview With FDA New Drugs Head John Jenkins (RPM Report-$)
  • OIG Digs Deep For Individual Responsibility at Endo (RPM Report-$)
  • Teva gains approval for generic Evista in the USA (Pharma Letter-$) (PMLive)
  • FDA lifts hold on Oxycyte; Oxygen Biotherapeutics soars (SCRIP-$) (Press) (Fierce)
  • Human germline engineering: The mom's not in the picture (BioWorld)
  • Generic Drug Cos. Push To Ax FTC Pay-For-Delay Suit (Law 360-$)

US: Pharmaceuticals and Biotechnology: Clinical Study Results, Filings and Designations

  • Sanofi, Regeneron's dupilumab shows rapid effect in atopic dermatitis (SCRIP-$)
  • Navidea Announces Acceptance for Review of an Additional sNDA to Further Expand Lymphoseek Labeling (Press)
  • Xoma drug fails to beat out a placebo in PhII osteoarthritis study (Fierce) (BioCentury)

US: Pharmaceuticals and Biotechnology: General

  • CDC's Frieden to Docs: Dial Back Antibiotic Rx (MedPage Today) (Scientific American) (NBC) (WSJ-$)
  • Insurers, Medicaid fear multibillion-dollar hepatitis C drug tab (Reuters)
  • Can Teva persuade payers that pricey long-acting Copaxone beats cheap generics? (Fierce)

US: Medical Devices

  • 4 Deaths Linked To Thoratec Heart System (Forbes) (WSJ-$) (FDA) (Bloomberg)
  • Medtronic Sued by 1,000 Infuse Patients (MedPage Today)
  • FDA Custom Device Exemption Still Won't See Much Use (Law 360-$)
  • First Carmat Heart Patient Dies 74 Days After Implant (Bloomberg)
  • Analysis of the Medical Device Pre-Submission Program Guidance (FDA Law Blog)
  • Blockade MedicalT Announces 510(k) Clearance and CE Mark of Two New Additions to the Barricade Coil System (Press)
  • AdvaMed Statement on President's FY 2015 Budget Proposal (AdvaMed)

US: Assorted And Government

  • Study examines gap in federal oversight of clinical trials (MNT)
  • FDA Launches openFDA Webpage (FDA)
  • FDA Launches openFDA Twitter Page (Twitter)
  • FDA Launches Rare Disease Education Portal (FDA)
  • FCA Claimants Closely Watching For Direction On Rule 9(b) (Law 360-$)
  • Supporting Innovative Research Through Regulatory Science (FDA)
  • Former FDA Economist: Pay Clinical Trial Participants for their Time (NYTimes)
  • HHS passes $1 trillion milestone (AP)

Europe

  • EMA finalizes guidance on process validation for manufacturers (In-Pharma)
  • Print adverts' prescribing info could be axed in UK (Pharmafile)
  • Adjusted EMA Fees Come Into Effect on 1 April 2014 (EMA)
  • Italian watchdog says Novartis, Roche colluded over eye drug (Reuters) (Bloomberg)
  • Critical review on the Environmental Risk Assessment of medicinal products for human use in the centralised procedure (Elsevier)
  • Report: U.K. facing $100M compensation payout relating to GSK's swine flu vaccine (Fierce)
  • Germany to join EU medicines verification system (Securing Industry)
  • VICH GL53 on Electronic exchange of documents: file format requirements (EMA)

India

  • Novartis may be fined for submitting 'fake' document to Drug Controller General of India (India Times)
  • India Trade Minister Accuses U.S. Of Protectionism Over CL, Other Issues (PharmAsia-$)

Japan & China

  • Takeda Japan candesartan promotion, study under scrutiny (SCRIP-$) (WSJ-$) (Fierce)

Other International

  • Russia Threatens to Seize Companies-Such as Pharmaceutical Companies-if EU, US Levy Sanctions (CNN)

General Regulatory And Interesting Articles

  • How Rare Disease Know-how Can Shape Big Pharma Clinical Trials (Life Science Leader)
  • Injections Providing Protection Against AIDS in Monkeys, Studies Find (NYTimes)

Regulatory Reconnaissance #269 - 5 March 2014

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 news@raps.org.


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