Regulatory Recon: FDA Examines Food Interactions With Abuse Deterrent Opioids (10 September 2015)

Posted 10 September 2015 | By Michael Mezher 

Regulatory Recon: FDA Examines Food Interactions With Abuse Deterrent Opioids (10 September 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

  • FDA Examines Food Interactions with Abuse Deterrent Opioids (Reuters) (MedPageToday) (Tarius 1, 2) (Pink Sheet-$)
  • In Appeal Over Colchicine 505(b)(2) Approval, Plaintiffs-Appellants and PhRMA Allege Lower Court Decision Upsets Hatch-Waxman Scheme (FDA Law Blog)
  • The legal gray area of medical device crowdfunding (MedCityNews)
  • FDA Releases MDSAP Mid-Pilot Status Report (FDA)
  • Vaginal mesh slings for incontinence fail in about 3 percent (Reuters)

In Focus: International

  • Time to Tailor New IVD Reg to IVD Industry: What Needs Changing at the 11th Hour (Clinica-$)
  • Drug companies may be told to upgrade facilities to meet PICS standards (Economic Times)
  • 39 Indian Drug Manufacturing Sites Currently Banned by US FDA (Financial Times)
  • Greece ends ban on parallel medicines traders (Politico)
  • EU court puts off Novartis access to rival data (Politico)

US: Pharmaceuticals and Biotechnology

  • Do Statins Work? UCSF Studies Pharmacogenomics of Statins (MedCityNews)
  • FDA Releases Guidance on ICH Q3D Elemental Impurities (FDA)
  • Is Axovant's Alzheimer's Drug The Real Deal, Or A Phantasm? (Forbes)
  • Merck's Keytruda: A Remarkable Science-To-Success Story  (SCRIP-$)
  • Glaxo shoots itself in the foot... again (EP Vantage)
  • Big Pharma misses the cut for new list of top healthcare tweeters (FiercePharmaMarketing)
  • More on Twitter and Pharma (Eye on FDA)
  • FDA pencils in two public meetings for NGS regulation (FierceDiagnostics) (Focus)
  • These Venture Capitalists Bet Big on a Miracle Fat Pill and Lost (Bloomberg)
  • 12 Steps To Recovery From FDA Form-483 Inspectional Observations (Gray Sheet-$)
  • A Multitude of Challenges Face Life Sciences Companies (Policy and Medicine)
  • Osteoporosis Drug Development; Public Workshop (FDA)

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

  • Chugai and Roche get U.S. FDA priority review on alectinib (FiercePharmaAsia) (Press)
  • Takeda's Ixazomib Granted Priority Review (PMLive)
  • Presbia Completes Second Stage Enrollment in the US FDA Pivotal Study of Presbia Flexivue Microlens (Press)
  • Lumicell Announces FDA Approval to Launch Feasibility Study in Gastrointestinal Cancers (Press)
  • Transgene Struggles With NSCLC Vaccine, Even As Positive Data Flow In (SCRIP-$)
  • Blueprint Medicines Receives FDA Authorization to Advance Novel Drug Candidate into Clinical Trial for Systemic Mastocytosis (Press)
  • BTG Announces FDA Acceptance of Wellstat Therapeutics’ New Drug Application for Uridine Triacetate as Antidote to Overexposure to Chemotherapy Drug 5-Fluorouracil (Press)
  • Drugs for Neglected Diseases initiative and Eisai Co., Ltd. to Test Drug Candidate for Eumycetoma (Press)
  • AcelRx (ACRX)'s Pain Drug Meets all Endpoints in Pivotal Phase III Study (BioSpace)
  • Dimension Therapeutics Announces FDA Acceptance of Investigational New Drug Application and Orphan Drug Designation for Lead Candidate DTX101 in Patients with Hemophilia B (Press)
  • Phase III data confirms efficacy of perampanel and rufinamide (EuropeanPharmaceuticalReview)
  • Clinical trial for first oral drug candidate specifically developed for sleeping sickness (MNT)

US: Medical Devices

  • Booz Allen On Track To Deliver CDRH Progress Report To Congress In February (Gray Sheet-$)
  • InVivo Therapeutics looks to expand spinal cage trial (MassDevice)
  • Rapid Molecular Diagnostic Device Spots Pathogenic DNA Within Four Minutes (medGadget)
  • The Z-lig Tendon Paves The Way for Xenographic ACL Transplants (medGadget)
  • Philips Receives FDA 510(k) Clearance for Spectral Diagnostic Suite (Press)
  • FDA clears Tandem Diabetes tslim: pump with DexCom’s G4 Platinum CGM (MassDevice) (FierceMedicalDevices)
  • Novel biodegradable implant 'captures' spreading cancer cells (MNT)
  • Japanese paper art inspires new 3-D fabrication method (MNT)

US: Assorted and Government

  • First Amendment Suit From Pacira Challenges FDA Labeling Interpretation (Pink Sheet-$)
  • Congressional Leaders Ask FDA About Coumadin Safety (ProPublica) (Focus)
  • Owner of Dietary Supplement Company Sentenced to Prison for Multimillion-Dollar Scheme to Adulterate Dietary Supplements (DoJ)
  • FDA Issues Draft Guidance on Distributor Labeling for New Animal Drugs (FDA)

Upcoming Meetings and Events


  • NICE set to recommend seven biologics for severe rheumatoid arthritis (PMLive)
  • EC grants marketing authorisation for Raxone in Leber’s Hereditary Optic Neuropathy (EuropeanPharmaceuticalReview)
  • Time To Tailor New IVD Reg to IVD Industry: What Needs Changing At The 11th Hour (Clinica-$)
  • QT Vascular wins CE Mark for drug-coated balloon (MassDevice)
  • Janssen submits MAA to EMA for daratumumab in multiple myeloma (PharmaLetter-$)
  • Stemline Therapeutics Announces SL-401 Receives EU Orphan Drug Designation for Treatment of Acute Myeloid Leukemia (AML) (Press)
  • UK parliament to debate calls to remove Hunt (PharmaTimes)


  • Health Canada grants marketing authorization to Recordati's Carbaglu (PharmaLetter-$)


  • Drug companies may be told to upgrade facilities to meet PICS standards (Economic Times)
  • CDSCO launches IT enabled system for online submission of applications & monitoring of clinical trials (PharmaBiz) (Focus)
  • Slew of upcoming forward looking polices by Central govt to transform pharma industry: DCGI (PharmaBiz)
  • How to fix India’s broken healthcare system without spending big money (Economic Times)

Ebola Outbreak

  • Sex and masturbation may hamper Ebola eradication efforts (Reuters)

Other International

  • KEI TPP Briefing Note: Conflicts with US legal norms and TPP provisions on IP remedies for infringement (KEI)

General Health and Other Interesting Articles

  • A giant ancient virus was just uncovered in melting ice (Washington Post)
  • Half of U.S. adults have diabetes or prediabetes (CBS News)
  • Regulators Halt Study of Cancer Risks at 7 Nuclear Plants (AP)

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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