Regulatory Reconnaissance: Apotex Put on Import Alert (2 April 2014)

Posted 02 April 2014 | By Alexander Gaffney, RAC 

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In Focus: US

In Focus: International

  • Europe Moves to Make Drug Trial Data More Transparent (Bloomberg)
  • New EMA User Fees Come Into Effect (EMA) (EMA) (SCRIP-$)
  • EDQM unveils falsified medicines database (Securing Industry) (In-Pharma)
  • Global Med Device Authorities Vary In Adoption Of Standards (Gray Sheet-$)
  • IMDRF Provides Update on Ongoing Activities (IMDRF)

US: Pharmaceuticals/Biotechnology

  • MannKind's inhaled insulin backed for US approval (PMLive) (SCRIP-$) (Pharma Letter-$) (NYTimes) (Bloomberg) (Reuters) (Pink Sheet-$) (MedPage Today) (BioCentury) (Fierce)
  • Canadian Generics Firm Apotex Put on Import Alert Over CGMP Failures at Indian Facility (FDA) (The Express)
  • U.S. Investigates Turkey's Ozay Pharma For Alleged Illegal Cancer Drugs (PharmAsia-$) (WSJ-$)
  • FDA Warnings to Body-Parts Vendors Overlooked by VA (Bloomberg)
  • Stallergenes wins U.S. go-ahead for Oralair allergy pill (Reuters) (Press) (Fierce)
  • Generic Labeling Reg Could Improve Sameness With Brand, FDA's Woodcock Says (Pink Sheet-$) (MM&M) (Reuters) (The Hill) (Law 360-$)
  • FDA Pushes For Greater Clinical Trial Patient Diversity (Law 360-$)
  • A Second Lawsuit Tests the BPCIA Biosimilars "Patent Dance" Waters (FDA Law Blog)
  • GPhA Releases White Paper on Enhancing ANDA Submissions (GPhA)
  • GSK Plans Recall After FDA Warning Over Tainted Batches (Law 360-$) (In-Pharma)
  • How Did A 30 Year Big Pharma Veteran Become An FDA Apologist? (Forbes)
  • Commercial Speech Issues Remain After FDA Guidance (Law 360-$)
  • Upcoming FDA Meeting on Pathway to Global Product Safety (FDA)
  • Number of FDA Debarments Continues to Fall (Lachman)
  • Push to Get Experimental Drugs With Social Media Pressure on the Rise (ABC)
  • When Compassion Isn't Enough (DrugWonks)
  • Lilly wins Alimta patent dispute with vitamin argument (SCRIP-$) (AP) (Reuters)
  • Study examines potential conflict of interest for leaders of academic medical centers serving on pharmaceutical boards (MNT) (AP) (ProPublica) (MedPage Today)
  • Pay-for-Delay Deals Increase Cancer Drug Costs (Clinical Oncology)
  • Is Gender a Drug Safety Issue in the Era of Personalized Medicine? (PharmExec)

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

  • GSK Drops Lung Cancer Vaccine After Failed Phase III Trial (Pharmafile) (Pharma Times) (PMLive) (GSK) (Fierce) (Reuters)
  • ERYTECH Receives Orphan Drug Designation by the FDA for ERY-ASP in Acute Myeloid Leukemia (Press)
  • FDA Fast Tracks IV and Oral Formulations of Eravacycline (Press)

US: Pharmaceuticals and Biotechnology: General

  • Hospitals coming up with new ideas to avoid drug shortages (MedCity News)
  • DARPA Boosts Funding for All Things Biological (IEEE)
  • The Sovaldi Case: Is American Biotech History About to Repeat Itself? (PharmExec)

US: Medical Devices

  • CDRH Looks to Drugs for Inspiration (MDDI)
  • New Chief Regulatory Officer for 23andMe (Press)
  • FDA Wants To Boost Premium Intraocular Lenses By Creating New Endpoints (Gray Sheet-$)
  • Review Finds Mammography's Benefits Overplayed, Harms Dismissed (NPR)
  • Boston Scientific's lead-free S-ICD looks good in 1st real-world study (Mass Device)
  • VertiFlex, Inc. Announces Submission of Final PMA Module to the FDA, for the Superion® Interspinous Spacer System (Press)
  • Rotation Medical Receives 510(k) Clearance for Implantable Collagen Scaffold Technology for Treating Rotator Cuff Disease (Press)

US: Dietary Supplements

  • FDA Seeking Comments On Import Alert Draft Guidance (FPD) (NPI)

US: Assorted And Government

  • PCORI's Anne Beal Joins Sanofi as Chief Patient Officer (Pharmafile) (SCRIP-$)
  • New HHS interactive video aims to protect research subjects (Fierce)
  • FDA Wants Automated Way to Conduct Translational Research (FDA)
  • FDA Seeks Legislative Tracking Services (FDA)


  • Europe Moves to Make Drug Trial Data More Transparent (Bloomberg)
  • New EMA User Fees Come Into Effect (EMA) (EMA) (SCRIP-$)
  • EDQM unveils falsified medicines database (Securing Industry) (In-Pharma)
  • Sanofi pulls Lyxumia in Germany (BioCentury)
  • IQWiG backs Roche's Kadcyla for some (BioCentury)
  • IQWiG backs Bayer's Xofigo (BioCentury)
  • IQWiG rebuffs Gilead's HIV drug Eviplera (BioCentury)
  • Medtronic under fire for payments in Scotland (Mass Device)
  • IEC 60601-1-2, 4th ed. (Electromagnetic disturbances in M.E.E. Environment) recently published (Eisner)
  • Alnylam Receives EU Orphan Drug Designation for ALN-TTRsc, a Subcutaneously Delivered RNAi Therapeutic for the Treatment of Transthyretin-Mediated Amyloidosis (Press)

Japan & China

  • Big Pharma's Rise in China not Held Back by Scandals (FT-$)

Other International

  • Global Med Device Authorities Vary In Adoption Of Standards (Gray Sheet-$)
  • IMDRF Provides Update on Ongoing Activities (IMDRF)
  • Australia Says its Closely Monitoring Novartis's MenB Vaccine bexsero Following Reports of Seizures (TGA)
  • GSK's ViiV unit adds new HIV drug to AIDS patent pool (GSK) (Reuters) (SCRIP-$)
  • MDMA compliance looming for Saudi Arabian medical device market (Mass Device)

General Regulatory And Interesting Articles

  • Expert: 'We lack the regulatory models' for next generation drugs (In-Pharma)
  • Residual solvents analysis aids counterfeit detection (Securing Industry)
  • Backed By a Billionaire, Berg Pharma Aims to Speed Drugmaking (Xconomy)

Regulatory Reconnaissance #289 - 2 April 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.

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