Regulatory Recon: LDT Developers, Nonprofit Labs Challenge Proposed FDA Regulations (14 October 2015)

Posted 14 October 2015 | By Michael Mezher 

Regulatory Recon: LDT Developers, Nonprofit Labs Challenge Proposed FDA Regulations (14 October 2015)

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing. Want to read Recon as soon as it's posted? Follow @Michael_Mezher, @Zachary Brennan and @RAPSorg on Twitter.

In Focus: US

In Focus: International                                                                                                

  • India battles big pharma over cough syrup abuse, reducing supplies (Reuters)
  • If you want new excipients, regulate them, says BASF (In-Pharma Technologist)
  • Pharma Companies in India May Pay Double penalty Violating GMP (Hindustan Times) (Economic Times)
  • 3 Ways Health Canada Could Simplify Compliance for Medical Device Companies (Emergo)
  • Health Canada requires doctor to sign confidentiality agreement to see drug data (CBC News)

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US: Pharmaceuticals and Biotechnology

  • FDA Nominee Commits to Advancing Translational Medicine (GEN)
  • U.S. prescription opioid misuse and deaths increase (Reuters)
  • Who decides the true value of a medicine? (Pharmaceutical Journal-$) (Focus)
  • One and Done: Are single pivotal studies the new norm in cancer therapeutics? (Cato Research)
  • Emerging Themes in Personalized Medicine (BiotechNow)
  • High Opioid Use In Elderly With Chronic Obstructive Pulmonary Disease, Study Finds (Forbes)
  • Anticancer effects of drugs overestimated by as much as 45 percent in animal models (MNT)
  • The Emergent Microbiome: A Revolution for the Life Sciences – Part III, Psychobiotics (Patent Docs) (Part I, II)

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

  • Psoriasis: one year data from Phase III study evaluating oral Otezla (apremilast) or injectable etanercept versus placebo (MNT)
  • CINRYZE Receives Fast Track Designation for Investigation in the Treatment of Antibody Mediated Rejection in Patients Receiving Kidney Transplants (Shire)
  • Ironwood's constipation drug meets main goal in late-stage study (Reuters)
  • Baricitinib Demonstrates Superiority to Adalimumab in Improving Signs and Symptoms of Rheumatoid Arthritis in Pivotal Phase 3 Study (Lilly)
  • Institute of Human Virology Begins Phase 1 Clinical Trials of HIV Vaccine Candidate (University of Maryland)

US: Medical Devices

  • Navigating Diagnostic Commercialization Process (National Law Review)
  • Draft Guidance: General Considerations for Animal Studies for Medical Devices (FDA)
  • The drug pricing backlash – Should medtech pay attention? (MassDevice)
  • Promega STR Analysis Kit Gets FBI Approval (GenomeWeb)
  • Medical Device Cybersecurity: 3 Vital Steps (HealthcareInfoSecurity)
  • Medtronic CoreValve® System Shows Positive Clinical Outcomes in New Patient Populations (Medtronic)
  • FDA Clears Baxter's Web-Connected Peritoneal Dialysis System (MedDeviceOnline) (Baxter)
  • NuVasive Receives First Ever FDA 510(k) Clearance Of Cervical Corpectomy Cage (MedDeviceOnline)
  • Non-invasive blood-based test shown to detect 92% of pancreatic cancer cases in samples from 59 individuals (MNT)
  • FDA Approves First Focused Ultrasound System For Treating The Prostate (MedDeviceOnline)

US: Assorted and Government

  • Lack of Warning Causation Dooms Aredia-Zometa Case (Drug and Device Law)
  • Sovereign Immunity in Texas for Warning Letters Sent by the Attorney General? The U.S. Court of Appeals for the 5th Circuit says, "Not so fast cowboy" (FDA Law Blog)
  • Sparks v. Oxy-Health, LLC, et al Summary Judgement Win Unsealed (Drug and Device Law)
  • Clinton, Sanders 'Proud' Pharma's An Enemy (SCRIP-$)

Upcoming Meetings and Events              


  • EMA To Shed More Light On Interactions With Industry (SCRIP-$)
  • NICE will charge industry to speed up drug approvals (Pharmaceutical Journal-$) (Focus) (PharmaPhorum) (SCRIP-$)
  • NICE can help NHS maintain public trust (OnMedica)
  • Getting Companies To Discuss Their Pediatric Research Plans Early: EMA Pilot Finally Gets Off To A Start (SCRIP-$)
  • ABPI comments on the official launch of NICE's new Office for Market Access (ABPI)
  • GSK Files Regulatory Application for Gel to Prevent Umbilical Cord Infections (FDANews-$)
  • EMA Explains Thinking On Exceptions To Trial Transparency (SCRIP-$)
  • Public consultation of the draft methodological guideline "Therapeutic medical devices" (EUnetHTA)
  • HeartWare: MVAD CE Mark Trial May Be Further Delayed (MDDI)
  • HeartMate III Left Ventricular Assist Device with MagLev Technology Cleared in Europe (medGadget)


  • Leaked IPR Draft To Revive India's Data Protection Bogey?  (SCRIP-$) (SpicyIP-Link to leaked draft)
  • No decision to allow sale of medicine using internet: JP Nadda (Economic Times)
  • Sub-committee on online pharmacy extends deadline till Oct 30 for comments & suggestions from stakeholders (PharmaBiz)
  • Chemists in Delhi join strike against online sale of drugs (Economic Times)
  • Chemists in Punjab, Haryana join strike against e-pharmacy (Economic Times)
  • DC depts in Tamil Nadu and Kerala ask traders' body not to interrupt medicine distribution system on Oct 14 (PharmaBiz)
  • 72,000 chemists in Maharashtra to shut shops on Oct 14 against e-pharmacy; FDA asks chemist assns to call off strike (PharmaBiz)
  • Apotex Inc recalls hypertension drug made by Indian arm (Economic Times)
  • FDA approves Aurobindo's Abilify generic (DSN)


  • Chinese firm says plans to 'mass produce' Ebola vaccine (Reuters)


  • Recall - Prism Medical P300 and C300 ceiling hoist (TGA)

Other International

  • Russia has no plans to introduce ban on drug imports (PharmaLetter-$)

General Health and Other Interesting Articles

  • Planned Parenthood revises reimbursement policy after video uproar (Reuters) (NPR)
  • A Tale of Do-It-Yourself Gene Therapy (MIT Technology Review)
  • Gene-editing method revives hopes for transplanting pig organs into people (Science) (Washington Post)
  • 'Supercoiled' DNA puts the simple double helix to shame (Washington Post)
  • Drug-Resistant E. coli Bacteria Increasingly Found in Community Hospitals (ICT)

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

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

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