Regulatory Focus™ > News Articles > Regulatory Reconnaissance: FDA, EMA Working on Biosimilar Data Guidance (24 April 2014)

Regulatory Reconnaissance: FDA, EMA Working on Biosimilar Data Guidance (24 April 2014)

Posted 24 April 2014 | By Alexander Gaffney, RAC 

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In Focus: US

  • FDA commissioner defends fast-track approval programs (Modern Healthcare)
  • FDA approves Janssen drug for rare Castleman's disease (PMLive) (Pharma Times) (BioCentury) (SCRIP-$) (FDA) (Press)
  • FDA Orders New Warning for Epidural Steroids (MedPage Today) (FDA) (Law 360-$) (FDA)
  • Biosimilars: FDA, EMA Developing Common Data Package Guidance (Pink Sheet-$)
  • AdvaMed casts a skeptical eye at FDA's new expedited approval idea (Fierce) (MDDI)
  • FDA Hopes To Balance Upfront Time Investment With Easier Reviews In New PMA Program (Gray Sheet-$)
  • FDA Taps Interim Director William Correll for Dietary Supplement Programs (NPI) (NI-USA)

In Focus: International

  • UK generics makers and MHRA pool manufacturing knowledge (In-Pharma)
  • Wockhardt Product Suspended by Local Indian Regulator (Reuters) (Fierce)
  • Generation of biobetters could push out biosimilar development, says expert (Biopharma Reporter)

US: Pharmaceuticals/Biotechnology

  • FDA commissioner defends fast-track approval programs (Modern Healthcare)
  • FDA approves Janssen drug for rare Castleman's disease (PMLive) (Pharma Times) (BioCentury) (SCRIP-$) (FDA) (Press)
  • FDA Orders New Warning for Epidural Steroids (MedPage Today) (FDA) (Law 360-$) (FDA)
  • Biosimilars: FDA, EMA Developing Common Data Package Guidance (Pink Sheet-$)
  • FDA Reassessing Off-Label Policies To Address First Amendment Concerns (Pink Sheet-$)
  • Sharfstein On Zohydro: FDA Should Require Opioid Abuse Deterrent Standards (Pink Sheet-$) (NEJM)
  • Recall Pending for OTC Cold Medicines Due to Subpotent Drugs (FDA)
  • FDA Says Pending Recall of Apotex's Risperidone Oral Solution Awaiting Classification, Due to Impurities and Degradation (FDA)

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

  • Amgen beats a path to the FDA, looking for an early approval of leukemia drug (Fierce)
  • FDA Fast Tracks OncoGenex Drug for Prostate Cancer (Press)
  • Bayer's Ciprofloxacin DPI Gets Orphan Drug Status (Press) (MM&M)

US: Pharmaceuticals and Biotechnology: General

  • Should we be able to pay for different levels of quality in our medicines? (AEI)
  • The federal government's insane restrictions on medical marijuana (Vox)
  • How much does it actually cost to manufacture sofosbuvir? (Scientific American)
  • Danielle Moon, Head Of MA & Drug Plan Division, To Leave CMS In May (IHP-$)
  • FDA's Adult Stem Cell Research Shows Promise (FDA)

US: Medical Devices

  • AdvaMed casts a skeptical eye at FDA's new expedited approval idea (Fierce) (MDDI)
  • FDA Hopes To Balance Upfront Time Investment With Easier Reviews In New PMA Program (Gray Sheet-$)
  • New Recall for Heartware's HVAD Pump Implant Kit (FDA)
  • Recall charges continue to suck up Stryker's profits (Mass Device)
  • Only Four Patients Have Been Implanted With FDA-Approved "Bionic Eye" So Far (NBC) (AP)
  • FDA Clears Siemens SOMATOM Force CT System (Press)

US: Dietary Supplements

  • FDA Taps Interim Director William Correll for Dietary Supplement Programs (NPI) (NI-USA)
  • The FDA Dietary Supplement Numbers Game (FDA Law Blog)
  • Herbalife punished 600 distributors for medical claims: ABC News (Reuters)
  • High Health Ad Standards May Hurt Consumers: FTC Commish (Law 360-$)

US: Assorted And Government

  • Pharmalink Consulting Being Acquired by Genpact (Pharmafile)
  • FDA Rips Providers For Shoddy Clinical Trial Oversight (Law 360-$)

Europe

  • UK generics makers and MHRA pool manufacturing knowledge (In-Pharma)
  • IQWiG finds added benefit for Novo Nordisk's NovoEight not proven (Pharma Letter-$)

India

  • Wockhardt Product Suspended by Local Indian Regulator (Reuters) (Fierce)

Japan & China

  • Bayer Submits Riociguat for PAH in Japan (Press)
  • Third Needle Found In Novartis Japan Voltaren Suppositories (PharmAsia-$)

General Regulatory And Interesting Articles

  • Long-time Reuters Journalist Debra Sherman Passes Away (Reuters)
  • Generation of biobetters could push out biosimilar development, says expert (Biopharma Reporter)
  • Conjuring Images of a Bionic Future (NYTimes)
  • Scientists think they can cure deafness with implants and DNA therapy (Vox)

Regulatory Reconnaissance #304 - 24 April 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.

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


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