Regulatory Focus™ > News Articles > Regulatory Recon: China Could Crackdown on Online Drug Sales (4 June 2014)

Regulatory Recon: China Could Crackdown on Online Drug Sales (4 June 2014)

Posted 04 June 2014 | By Alexander Gaffney, RAC 

Regulatory Recon: China Could Crackdown on Online Drug Sales (4 June 2014)

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing. Read anything we might be interested in sharing? Let us know: news@raps.org.

In Focus: US

  • The End of the REMS Era? Entyvio Approval Is Another Marker (RPM Report-$)
  • Empagliflozin Approval May Come This Year After Boehringer Resolves GMP Problems (Pink Sheet-$) (Fierce)
  • Adverse Event Search Site Already Using FDA's openFDA API (Open FDA Search)
  • Pharma Is Tossed From Lawsuit About Internet Pharmacies (Pharmalot)
  • Health apps boom while regs lag (Politico)
  • Medical device maker HeartWare gets FDA warning letter (Reuters) (Heartware)
  • Supplement Group Poaches #2 FDA Supplement Regulator, Weeks After Getting its Top Regulator  (NI-USA) (NPI)

In Focus: International

  • China FDA May Not Allow Manufacturers, Wholesalers To Sell Drugs To Individuals Online (PharmAsia-$) (CFDA)
  • Covidien's 3-in-1 Nellcor monitoring gets E.U. approval (Mass Device)
  • Ombudsman 'not satisfied' with EMA's explanation of disclosure policy changes (SCRIP-$)
  • UK scientific panel backs potential 'three-parent' IVF babies (Reuters) (AP)
  • Russia Signs EU Agreement on Drug Precursors (Eur-Lex) (Eur-Lex) (Eur-Lex)
  • Australia Looking to Reform its Pharmaceutical Compounding System (TGA)

US: Pharmaceuticals/Biotechnology

  • The End of the REMS Era? Entyvio Approval Is Another Marker (RPM Report-$)
  • Empagliflozin Approval May Come This Year After Boehringer Resolves GMP Problems (Pink Sheet-$) (Fierce)
  • Adverse Event Search Site Already Using FDA's openFDA API (Open FDA Search)
  • Pharma Is Tossed From Lawsuit About Internet Pharmacies (Pharmalot)
  • April OGD Statistics Just Published – Let’s Look at the Numbers a Bit Differently (Lachman)
  • Regulatory and cost barriers are likely to limit biosimilar development and expected savings in the near future (PubMed)
  • Delaware governor signs new biosimilar law requiring prescriber notifications (Biopharma Reporter)
  • ASCO Provides Input on U.S. House Committee White Paper on Accelerating Progress in Care (ASCO)
  • FDA Releases DSCSA Data Exchange Public Workshop Readout (TraceLink)
  • Sandoz Gets Claims Nixed In UTC’s Generic Remodulin Fight (Law 360-$)
  • Cubist plans to block rival from selling generic version of its antibiotic (BioFlash)

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

  • ASCO 2014: Lilly's necitumumab fails to impress with SQUIRE (SCRIP-$)
  • ASCO 2014: Pivotal Phase III Data in Polycythemia Vera Show that Jakafi (ruxolitinib) Achieved Superior Disease Control Compared to Best Available Therapies (Press)
  • Vertex: Proof-of-Concept Study of Ivacaftor Monotherapy Showed Improvements in Lung Function After Two Weeks of Treatment in People with Cystic Fibrosis who have a Residual Function Mutation (Press)
  • Affiris: Breakthrough in Alzheimer's Disease: AFFiRiS Halted Clinical Progression in Alzheimer Patients Upon Treatment With AD04 in a Phase II Clinical Study (Press)

US: Pharmaceuticals and Biotechnology: General

  • Do Drug Companies Make Drugs, or Money? (NYTimes Dealbook)
  • Industry Observer Ed Silverman Resurrects His Pharmalot Blog for a Third Time, Now on WSJ (Pharmalot)
  • Drug-makers volley attack against insurers over O-Care subsidies (The Hill)

US: Medical Devices

  • Health apps boom while regs lag (Politico)
  • Medical device maker HeartWare gets FDA warning letter (Reuters) (Heartware)
  • Devicemakers celebrate early regulatory wins despite 2013 setbacks (Fierce)
  • Will OpenFDA trigger a rush of mHealth apps? (mHealthNews)
  • Medtronic: Solicitor General got it wrong on preemption (Mass Device)
  • OsteoSymbionics scores FDA clearance for craniofacial implant (Fierce)
  • CenterVue Announces FDA Clearance of Next Generation Macular Integrity Assessment (MAIA) (Press)

US: Dietary Supplements

  • Supplement Group Poaches #2 FDA Supplement Regulator, Weeks After Getting its Top Regulator  (NI-USA) (NPI)
  • US: Assorted And Government
  • New FDA Warning Letters Posted (FDA)
  • E&C to Hold Next "Path to Cures" on 11 June 2014 (Twitter)
  • FDA Releases Huge Solicitation for a "Fully Integrated" Offsite Document Control Center (FDA)
  • New FDA Guidances for May 2014 (Ask-Cato)
  • Highlights From AP Interview With FDA's Hamburg (AP)
  • Compliance Challenges within Medical Affairs (Policy and Medicine)

Europe

  • Covidien's 3-in-1 Nellcor monitoring gets E.U. approval (Mass Device)
  • Ombudsman 'not satisfied' with EMA's explanation of disclosure policy changes (SCRIP-$)
  • UK scientific panel backs potential 'three-parent' IVF babies (Reuters) (AP)
  • INVEGA receives European Commission approval to extend its adult indication for treatment of schizophrenia to include adolescents aged 15 years and older (Press)

India

  • IPA president calls to synchronise regulatory compliances in manufacture for export & domestic markets (PharmaBiz)
  • Maharashtra to get first online system for speedy issue of drug manufacturing licenses (PharmaBiz)
  • IPC meets AMC co-ordinators to discuss measures to strengthen ADRs (PharmaBiz)

Japan & China

  • China FDA May Not Allow Manufacturers, Wholesalers To Sell Drugs To Individuals Online (PharmAsia-$) (CFDA)

Other International

  • Russia Signs EU Agreement on Drug Precursors (Eur-Lex) (Eur-Lex) (Eur-Lex)
  • Australia Looking to Reform its Pharmaceutical Compounding System (TGA)
  • Pakistan Parliament Panel Urges Drug Registration Placed On War Footing (PharmAsia-$)
  • Mexican regulators clarify stance on importation of medical devices during renewal periods (Mass Device)

General Regulatory And Interesting Articles

  • Was the flu drug zanamivir a breakthrough or money for old rope? (BMJ-$)
  • What to do about the deadly threat of substandard drugs (AEI)
  • The Graying of Clinical Trials (PharmExec)

Regulatory Reconnaissance #331 – 4 June 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.

Did we miss a story? Send us a tweet at @RAPSorg and we'll check it out for inclusion in our next edition of Regulatory Reconnaissance. Want this in your inbox each morning? Sign up for RF Today, our morning intelligence newsletter here.

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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