Regulatory Focus™ > News Articles > Regulatory Recon: WHO Finds Evidence of Data Manipulation at Indian CRO (7 July 2015)

Regulatory Recon: WHO Finds Evidence of Data Manipulation at Indian CRO (7 July 2015)

Posted 07 July 2015 | By Michael Mezher 

Regulatory Recon: WHO Finds Evidence of Data Manipulation at Indian CRO (7 July 2015)

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

In Focus: US

  • AstraZeneca and Cephalon Settle Medicaid Rebate Allegations (Reuters) (DoJ)
  • FDA Pulls Biologics License From Long Defunct Firm (FDA) (FDANews-$)
  • Effective Use of Foreign Clinical Trial Data: Best Practice Considerations (MDDI)
  • Fight Over Affordable Care Act Turns to Medical-Device Tax (WSJ-$)
  • BIO and NORD Defend Orphan Drug Tax Credit in New Report (Report) (FDA Law Blog)
  • Amarin First Amendment Suit Against FDA Enters Oral Argument (Drug and Device Law)
  • FDA Draft Guidance on Fibrinogen Biomarker Qualification (FDA) (BioCentury)
  • Theranos gets unnecessary FDA clearance for its cheap, fingerstick blood tests (MobiHealthNews)

In Focus: International

  • WHO Finds Evidence of Data Manipulation at Indian CRO Quest Life Sciences (WHO) (Economic Times) (Outsourcing Pharma)
  • Israel and Brazil Cleared to Ship APIs to Europe Without Certification (In-Pharma Technologist) (FiercePharmaManufacturing) (EC)
  • Analysis of new draft regulation for medical devices in South Korea (Emergo Group)
  • To Improve Medicine Safety, EMA is Publishing Safety Reports of Nationally Authorised Medicines (EMA)
  • EMA Adopts Seven Bioequivalence Guides (EMA, See Annex C)
  • EMA Updates Pre- and Post-Authorization Procedural Advice for Centralised Procedure, Track Changes (EMA) (EMA)

US: Pharmaceuticals and Biotechnology

  • FDA Draft Guidance on Fibrinogen Biomarker Qualification (FDA) (BioCentury)
  • FDA Pulls Biologics License From Long Defunct Firm (FDA) (FDANews-$)
  • AstraZeneca and Cephalon Settle Medicaid Rebate Allegations (Reuters) (DoJ)
  • BIO and NORD Defend Orphan Drug Tax Credit in New Report (Report) (FDA Law Blog)
  • Retrophin Completes Sale of Priority Review Voucher for $250 Million (Press)

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

  • Eli Lilly preps a familiar case for FDA review of a marginal cancer drug (FierceBiotech)
  • FDA puts Catabasis' DMD therapy on Fast Track (BioCentury) (Press)
  • NIH-funded vaccine for West Nile virus enters human clinical trials (NIH)
  • Two potential biomarkers for severe heart disease in insulin resistance found (MNT)
  • Dyax Receives Breakthrough Therapy Designation for Hereditary Angioedema Drug (Press)
  • FDA Lifts Partial Clinical Hold on Versartis VRS-317 Phase III Trial (FierceBiotech) (SCRIP-$) (Press)
  • Pfizer Starts Phase IIb Trial for Staphylococcus aureus Vaccine (Press)
  • Thrasos Completes Enrollment of Phase 2 THR-184 Clinical Study for Acute Kidney Injury (Press)

US: Pharmaceuticals and Biotechnology: General

  • Serious Risks And Few New Benefits From FDA-Approved Drugs (Health Affairs Blog)
  • NSURE in Play if Not Yet in FDA's Regulatory Playbook (Tan Sheet-$)

US: Medical Devices

  • Theranos gets unnecessary FDA clearance for its cheap, fingerstick blood tests (MobiHealthNews)
  • Effective Use of Foreign Clinical Trial Data: Best Practice Considerations (MDDI)
  • From MDR to CAPA: 6 Questions Answered By FDA Investigators (Grey Sheet-$)
  • Medtronic Study Shows Varicose Vein Adhesive Comparable to Ablation Treatment (FierceMedicalDevices) (Press)
  • FDA Clears BG Medicine Automated Chronic Heart Failure Test (FierceDiagnostics) (Press)
  • Cardiovascular Systems' Next-Gen Guide Wire Gains FDA Clearance (Press)

US: Assorted and Government

  • Fight Over Affordable Care Act Turns to Medical-Device Tax (WSJ-$)
  • Transparency Program Obscures Pharma Payments to Nurses, Physician Assistants (ProPublica)
  • Amarin First Amendment Suit Against FDA Enters Oral Argument (Drug and Device Law)

Upcoming Meetings and Events

Europe

  • Israel and Brazil Cleared to Ship APIs to Europe Without Certification (In-Pharma Technologist)  (FiercePharmaManufacturing) (EC)
  • NHS England approves routine commissioning for Parkinson's treatment Duodopa (MNT)
  • To Improve Medicine Safety, EMA is Publishing Safety Reports of Nationally Authorised Medicines (EMA)
  • EMA Adopts Seven Bioequivalence Guides (EMA Annex C)
  • EMA Updates Pre- and Post-Authorization Procedural Advice for Centralised Procedure, Track Changes (EMA) (EMA)
  • Latest PIP implant ruling: good news for notified bodies, bad news for medtech's rep (Clinica-$)

India

Japan

Other International

  • Analysis of new draft regulation for medical devices in South Korea (Emergo Group)
  • Local drugmakers in Nigeria kick against new government policies (PharmaLetter-$)

Ebola Outbreak

  • Ebola-stricken nations need $700 million to rebuild healthcare (Reuters)

General Regulatory and Interesting Articles

  • UN Details Progress on Millennium Development Goals (UNDP) (Report)

Regulatory Reconnaissance #590 – 7 July 2015

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.

Need to contact the editor of Regulatory Reconnaissance? Find him on Twitter at @Michael_Mezher or send him an email at news@raps.org.

A story's inclusion in Regulatory Reconnaissance does not imply endorsement by Regulatory Focus or RAPS.


Categories: Recon, Regulatory News

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