Regulatory Focus™ > News Articles > Regulatory Recon: Regulation of Stem Cells Challenges FDA (19 May 2015)

Regulatory Recon: Regulation of Stem Cells Challenges FDA (19 May 2015)

Posted 19 May 2015 | By Alexander Gaffney, RAC

Regulatory Recon: Regulation of Stem Cells Challenges FDA (19 May 2015)

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

In Focus: US

  • Stem cell 'Wild West' takes root amid lack of US regulation (AP)
  • Animal Compounding Guidance (Draft) for Use of Bulk Drug Substances Released by FDA (FDAlife) (FDA) (FDA) (FDA) (FDA)
  • Overuse, Safety Questions Cloud Advair’s Ascent to Asthma Blockbuster (ProPublica)
  • The Broader Commerce Clause Implications of Drug Take-back Laws (WSJ-$)
  • Device for acid reflux approved by FDA, but not by insurers (StarTribune)
  • UDI Rule a Challenge for Ortho Company (MDDI)
  • FDA says no to CBD in supplements (NI-USA)
  • How Will Congress Pay for the 21st Century Cures Act? (Politico)

In Focus: International

  • EMA picks Pluristem's PLX-PAD for adaptive pathway pilot (BioCentury)
  • MEPs propose blueprint for safer use of antibiotics (EuroParl)
  • Inspection Of Tissue And Cell Procurement And Tissue Establishments: Operational Manual For Competent Authorities (EC)
  • India’s Evolving IPR Policy Stance Masks Underlying Healthcare Challenges (24 Insight)
  • DCGI assures safety of imported medical devices to India (PharmaBiz)
  • Collaboration Key For China Regulatory Reforms, RDPAC Says (PharmAsia-$)
  • China scraps 15% drug markup at 100 hospitals, to move nationwide by 2017 (Fierce)

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US: Pharmaceuticals and Biotechnology

  • Stem cell 'Wild West' takes root amid lack of US regulation (AP)
  • Animal Compounding Guidance (Draft) for Use of Bulk Drug Substances Released by FDA (FDAlife) (FDA) (FDA) (FDA) (FDA)
  • Overuse, Safety Questions Cloud Advair’s Ascent to Asthma Blockbuster (ProPublica)
  • The Broader Commerce Clause Implications of the Alameda Drug Take-back Law (WSJ-$)
  • In Switch Label Studies, FDA Carefully Reads Data On Low-Literacy Consumers (Tan Sheet-$)
  • Another Punt Return Resolving 180-Day Exclusivity; This Time a True Post-MMA Case Made in the Context of Lamotrigine Orally Disintegrating Tablets (FDA Law Blog)
  • Patient Advocate Says 'Cures' Registry Provisions Worry FDA Scientists (IHP-$)
  • FDA Issues Letters to Doctors Who May Have Purchased Counterfeit or Unapproved Prescription Drugs (FDA)
  • Gardasil Clears Safety Review: No Link To VTE, Mini-Sentinel Study Finds (Pink Sheet-$)
  • U.S. FDA Approves INVEGA TRINZA, First and Only Four-Times-A-Year Treatment for Schizophrenia (Press)
  • Citizen petitions seek to defend Aloxi (FDA) (FDA)
  • CDC: NECC compounding crisis could have been worse (SCRIP-$) (CDC)

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

  • Regeneron speeds toward the FDA with its would-be asthma blockbuster (Fierce) (Press) (SCRIP-$)
  • pSivida Reports Positive IOP Safety Data in Phase III Trial of Medidur for Posterior Uveitis (Press)
  • Debiopharm International SA Announces Phase III Positive Results for Triptorelin 6-month Formulation in the Management of Central Precocious Puberty (CPP) (Press)
  • bluebird bio Announces Global Regulatory Strategy for LentiGlobin BB305 in Beta-Thalassemia Major (Press)
  • Novo Nordisk weighs diabetes drug's use in fatty liver disease (Reuters)

US: Pharmaceuticals and Biotechnology: General

  • How BIO, PhRMA aim to get IPR reform into Senate's patent bill (BioCentury-$)
  • Superbug summit: White House to hold antibiotics forum (SCRIP-$)

US: Medical Devices

  • Device for acid reflux approved by FDA, but not by insurers (StarTribune)
  • FDA-CMS Parallel Review Pilot Will Be Extended; Drugs Not The Focus (RPM Report-$)
  • UDI Rule a Challenge for Ortho Company (MDDI)
  • Shuren: LDT Reliability Critical To Precision Medicine Initiative (Gray Sheet-$)
  • Medtronic trumpets positive data for Tyrx antibacterial envelope in high-risk patients (Fierce)
  • Apollo's minimally invasive intragastric weight-loss balloon shows promise in clinical trial (Fierce)
  • Olympus Sued In Pa. Over FDA-Flagged Uterine Surgery Tool (Law 360-$)
  • FDA grants waiver for Roche's cobas Strep A test (Reuters) (Press)
  • BrainScope’s Ahead 200 Device Cleared by FDA for Adjunctive Assessment of Traumatic Brain Injury (Press)
  • Cynosure Receives FDA 510(k) Clearance for SculpSure, the World's First Hyperthermic Laser Treatment for Non-Invasive Fat Reduction (Press)
  • Nitiloop Announces FDA 510(k) Clearance for its NovaCross Microcatheter for Support of Guidewire Access to Discrete Regions of the Coronary and Peripheral Vasculature (Press)
  • FDA Grants Premarket Approval for Silk Road Medical's ENROUTE Transcarotid Stent System (Press)

US: Dietary Supplements

  • FDA says no to CBD in supplements (NI-USA)
  • Extending GMPs to ingredient suppliers would fix gap in original rule, stakeholders say (NI-USA)
  • Caffeine Powder Poses Deadly Risks (NYTimes)

US: Assorted And Government

  • How Will Congress Pay for the 21st Century Cures Act? (Politico)
  • Presidential Contender Bernie Sanders Takes Aim at High Drug Prices (The Hill) (Law 360-$)
  • WTO Rejects US Country of Origin Labeling Rule (AP) (WSJ-$)
  • U.S. FDA considers expanding tests for drug residues in milk (Reuters)

Upcoming Meetings and Events

Europe

  • EMA picks Pluristem's PLX-PAD for adaptive pathway pilot (BioCentury)
  • MEPs propose blueprint for safer use of antibiotics (EuroParl)
  • Inspection Of Tissue And Cell Procurement And Tissue Establishments: Operational Manual For Competent Authorities (EC)
  • Stakeholders Seek Clarification on New EU GMP Annex 15 Mandates (FDA news-$)
  • Scotland doubles cash for new medicines fund (PharmaTimes)
  • European Medicines Agency post-authorisation procedural advice for users of the centralised procedure (EMA)
  • NICE guidance on AMD will not give advice on Avastin (SCRIP-$)
  • Arterial Remodeling wins CE Mark for bioreabsorbable stent (MassDevice)

India

  • India’s Evolving IPR Policy Stance Masks Underlying Healthcare Challenges (24 Insight)
  • DCGI assures safety of imported medical devices to India (PharmaBiz)

China

  • Collaboration Key For China Regulatory Reforms, RDPAC Says (PharmAsia-$)
  • China scraps 15% drug markup at 100 hospitals, to move nationwide by 2017 (Fierce)
  • JD.com, Shanghai Pharma to develop online pharmacy (BioSpectrumAsia-$)

Australia

  • Australia, pharmacy body near agreement on budget subsidies for medicines (Fierce)

Other International

  • Malaysian device applicants warned over fast-approaching deadline (Clinica-$)

General Regulatory And Interesting Articles

  • A Way to Brew Morphine Raises Concerns Over Regulation (NYTimes)
  • U.S. science leaders to tackle ethics of gene-editing technology (Reuters) (Washington Post)
  • Is nicotine all bad? (Reuters)
  • 3D printed human skin is L’Oreal’s next big thing (Washington Post)
  • Study Suggests Dense Breast Tissue Isn’t Always a High Cancer Risk (NYTimes)

Regulatory Reconnaissance #560 – 19 May 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 @AlecGaffney 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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