Regulatory Recon: What You Missed Over the Holidays (4 January 2016)

Posted 04 January 2016 | By Michael Mezher 

Regulatory Recon: What You Missed Over the Holidays (4 January 2016)

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

  • Drug approvals at 19-year high belie industry challenges (Reuters)
  • FDA Regulator, Widowed by Cancer, Helps Speed Drug Approval (NYTimes)
  • E-cigarettes. Generic drugs. A guide to the FDA in 2016 (STAT)
  • FDA to take more aggressive stance on medical device safety warnings (STAT) (FDA)

In Focus: International

  • China Should Fix Its Drug Problem (Here's How) (Bloomberg)
  • GVK Biosciences row: India, EU to meet on Jan 18 in Brussels (Economic Times)
  • Cadila gets US FDA warning for violating standards at Moraiya and Ahmedabad plants (Economic Times) (SCRIP-$)
  • Latin American Countries Set Up Joint Procurement Mechanism For Drugs (SCRIP-$)
  • Canada Sets Jan 2019 Deadline For Mandatory Adoption Of MDSAP Within Medtech Framework (SCRIP-$)

US: Pharmaceuticals and Biotechnology

  • FDA 2015: A Look Back (and Ahead) – Part 1: Medical Product Innovation (FDA Voice)
  • New Life for the Pediatric Priority Review Voucher Program (FDA Law Blog)
  • A Year in Review: Important Intel Gleaned from CDER Report on New Drug Approvals (FDA Law Blog)
  • FDA Invites Patient Organizations to Take a Place at the Podium (FDA Voice) (Federal Register)
  • Success Rate for Biopharma Companies Rising as FDA Approves Near-Record Number of (Thomson Reuters)
  • FDA Enforcement on Promotional Communications – 2015 Summary (Eye on FDA)
  • Peeling the Onion: How to Promote Pharmaceutical Innovation and Access to Medicine (Harvard Bill of Health)
  • FDA Excipient Database Plagued By Inaccuracies, Causes Confusion (Tan Sheet-$)
  • Rat Study Links Neural Tube Defects To Lower PCSK9 Levels (CadrioBrief)
  • Chimerix antiviral drug fails, shares plummet to record low (Reuters)
  • Why Preventing Cancer Is Not the Priority in Drug Development (NYTimes)
  • US Army Gets FDA (Re)Approval Of Pyridostigmine Bromide For Military Protection Against Nerve Gas (Forbes)
  • This Lung Cancer Drug May Not Be What It Seems, Chemists Say (Forbes)
  • Should Prescription Drug Monitoring Programs Include Opioid Overdoses? (Forbes)
  • Bioequivalence Recommendations for Paliperidone Palmitate; Draft Guidance for Industry (FDA)
  • FDA Calls for Input on Clinical Trial Designs in Emerging Infectious Diseases (FDA)
  • A fifth of cancer therapy trials fail to enlist enough participants (MNT)

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

  • FDA grants orphan drug designation to Pluristem's PLX-PAD cells for treatment of severe preeclampsia (MNT)
  • Gene Therapy To Treat HIV In Clinical Trial (Forbes)
  • New NIH-funded memory drug moves into Phase 1 clinical study (NIH)
  • Rich Pharmaceuticals, Inc. Receives FDA Approval for a Phase 1/2 Study in AML & MDS (Press)
  • Nanobiotix: FDA Approved Investigational New Drug for NBTXR3 in a New Clinical Study in Prostate Cancer (Press)
  • Amarantus Requests Rare Pediatric Disease and Orphan Drug Designations from US FDA for Engineered Skin Substitute in the Treatment of Giant Congenital Melanocytic Nevi (Press)
  • FDA Grants Rare Pediatric Disease Designation to REGENXBIO's RGX-111 Gene Therapy for the Treatment of Mucopolysaccharidosis Type I (Press)
  • Global Blood Therapeutics Receives FDA Orphan Drug Designation for GBT440 in Sickle Cell Disease (Press)
  • Epizyme Announces FDA Acceptance of Investigational New Drug Application for Tazemetostat in Diffuse Large B-cell Lymphoma (Press)
  • MabVax Therapeutics Announces FDA Authorization to Proceed with HuMab-5B1 in a Phase I Clinical Trial for the Treatment for Pancreatic Cancer (Press)
  • Pfizer's Phase 3 Study of Pristiq in MDD Misses Primary Endpoint (DD&D)

US: Medical Devices

  • FDA releases FY2016 planned guidance docs (MassDevice) (FDA)
  • The New and Improved 510(k) RTA: Permitting FDA Discretion (FDA Law Blog)
  • The Theranos scandal should be a wake-up call. Here are 4 reasons it won't be (STAT)
  • FDA clears FujiFilm reprocessing label for 'superbug'-susceptible duodenoscopes (MassDevice)
  • Plan Carefully In Writing Combo Product Designation Requests, Experts Say (Gray Sheet-$)
  • Medical Device User Fee and Modernization Act; Notice to Public of Web Site Location of Fiscal Year 2016 Proposed Guidance Development (FDA)
  • Draft Guidance: Electroconvulsive Therapy (ECT) Devices for Class II Intended Uses (FDA, Reclassification)
  • Class I Recall: bioMérieux SA Etest® PIP/TAZO/CON-4 PTC 256 – Potential for Test Result Error (FDA)
  • Dario, a Tiny Smartphone-Powered Glucometer FDA Cleared (medGadget)
  • FDA clears Biotronik's full-body MRI-safe Iperia ICDs (MassDevice)

US: Assorted and Government

  • Getting Past Gatekeeper: "No Shoes, No Shirt, No Service" re: Admissibility of Expert (National Law Review)
  • The Saga of Preempting Prescription Drug Design Defect Claims (Drug and Device Law)
  • Court Speeds Up Apotex Appeal In Amgen Biosimilar Suit (SCRIP-$)
  • This Could Be A Monumental Year For The 340B Program (Law360-$)
  • FDA Issues Proposal on Prescription and OTC Fixed-Combination and Co-Packaged Products (FDA Law Blog)
  • Any Given Patient for Any Given Indication: AbbVie Petitions FDA on Interchangeable Biosimilars (FDA Law Blog)
  • Supreme Court Review Of Biosimilars Law Closer? (SCRIP-$)

Upcoming Meetings and Events              


  • Current State of Data Protection and Exclusivity in Russia (National Law Review)
  • NICE changes position on NHS use of Ezetrol (PharmaTimes)
  • Draft concept paper on the revision of the reflection paper on non-clinical and clinical development of similar biological medicinal products containing recombinant interferon alpha or pegylated recombinant interferon alpha (EMA)
  • Sunesis Pharmaceuticals Announces European Medicines Agency Validates Marketing Authorization Application for Vosaroxin in AML (Press)


  • Orchid Pharma gets EIR report from USFDA on inspection closure (Economic Times)
  • Make way for automatic compulsory licensing in pharma: RSS (Economic Times)
  • Regulators gear up to offset challenges as pharma procurement & supply chain turn complex: Dr Sharad Mankumare (PharmaBiz)
  • Full implementation of DAVA project to check fake drugs export (Economic Times)
  • IDMA urges DCGI not to make phase IV trial mandatory to justify irrational FDCs (PharmaBiz)
  • Online Retailers of Medicines in India Must Comply With Drugs & Cosmetics Act (24 Isnight)
  • Faster Customs Clearance for Imported Drugs in India? (24 Insight)
  • Bayer Schering Pharma Deemed to Have Lost Interest in Indian Patent Application (24 Insight)
  • Indian Patents Controller Grants Patent to Amgen For its Anti-GM-CSF Mab (Namilumab) (24  Insight)
  • Indian API Manufacturer, SMS Pharmaceuticals, Reports Successful USFDA Inspection (24 Insight)
  • Indian Drugmaker Takes Second Shot With Its Generic Nexium (WSJ-$)
  • Aurobindo receives FDA approval for famotidine tablets (DSN)
  • Lupin gets FDA approval for generic Femhrt (DSN)


  • Yisheng BioPharma gets positive result in rabies vaccine trial (BioSpectrum)
  • CFDA issues new drug certificate and production license for Sinovac's EV71 vaccine (Press)


  • Teikoku Pharma gets USFDA nod for non-alcohol docetaxel injection (BioSpectrum)

Other International

  • South Korea Tightens Regulation on Stem Cell Drugs (KBS)

General Health and Other Interesting Articles

  • Whatever Happened To Industry's Interest In Ebola? (SCRIP-$)

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.

Categories: Recon, Regulatory News

Regulatory Focus newsletters

All the biggest regulatory news and happenings.


Most Viewed Articles