Regulatory Focus™ > News Articles > Regulatory Reconnaissance (6 November 2013)

Regulatory Reconnaissance (6 November 2013)

Posted 06 November 2013 | By Alexander Gaffney, RAC 

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.

Editor's Note: Apologies for the later-than-usual Regulatory Recon.

In Focus: US

  • China Has Still Not Issued FDA Visas To Boost Inspection Staff (Pharmalot) (In-Pharma)
  • Vitter's Demands Hold Up Compounding-Pharmacy Bill (Bloomberg)
  • FDA not sold on pharmacy compounding bill (The Hill)
  • Hamburg, Like Industry, Wants Predictability - But In FDA Funding (Pink Sheet-$)
  • PhRMA Says Loophole Allows Plaintiffs To Extract Big Settlements (IHP-$)
  • Draft and Revised Draft Guidances for Industry Describing Product-Specific Bioequivalence Recommendations; Availability (FDA)
  • FDA puts a clamp on Curis cancer drug program after patient dies of liver failure (Fierce) (Xconomy)

In Focus: International

US: Pharmaceuticals/Biotechnology

  • China Has Still Not Issued FDA Visas To Boost Inspection Staff (Pharmalot) (In-Pharma)
  • Vitter's Demands Hold Up Compounding-Pharmacy Bill (Bloomberg)
  • FDA not sold on pharmacy compounding bill (The Hill)
  • Draft and Revised Draft Guidances for Industry Describing Product-Specific Bioequivalence Recommendations; Availability (FDA)
  • FDA puts a clamp on Curis cancer drug program after patient dies of liver failure (Fierce) (Xconomy)
  • Johnson & Johnson, Risperdal And A Lack Of Clinical Trial Disclosure (Pharmalot)
  • GDUFA Communication Policy Riles Companies, But FDA Not Backing Off (IHP-$)
  • The Next Phase In Oncology: FDA's Pazdur On "Breakthrough" Drug Development (RPM Report-$)
  • Woodcock Committed to New Drug Quality Office (PharmTech Talk)
  • FDA's Approach To Combination Pediatric Therapies: Monotherapy Comes First (Pink Sheet-$)
  • Analyst's worst-case on Brilinta probe? Feds force AstraZeneca blood thinner off market (Fierce) (Pharmalot) (Fierce)
  • Phase III Results Give Shire's Vyvanse A Boost In Binge Eating (Pink Sheet-$) (DD&D) (Guardian) (Pharma Letter-$) (SCRIP-$) (Pharma Times) (EP Vantage-$) (BioCentury)
  • Risk-based Monitoring vs Traditional Monitoring: the ADAMON Project (Polaris)
  • Determination That MOBAN Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness (FDA)
  • Draft Guidance for Industry on Bioequivalence Recommendations for Iron Sucrose; Availability (FDA)
  • Level of Industry Response to FDA's Quality Agreement Draft Guidance Reflects Contracting Challenges; Terminology at Issue (IPQ-$)
  • Testosterone tied to heart risks among older men (Forbes) (Cardiovascular Business) (Reuters) (NBC) (Bloomberg)
  • Advaxis' ADXS-HPV Granted Orphan Drug Designation for Treatment of HPV-Associated Head and Neck Cancer (Press)
  • UCB files Vimpat for expanded epilepsy use (PMLive)
  • Aeterna submits NDA for AGHD diagnostic (BioCentury)
  • Study finds similar patient responses between branded arthritis treatment, Hospira biosimilar (DSN)
  • Keryx says kidney drug effective; shares hit seven-year high (Reuters) (BioCentury) (Fierce)
  • First details of lurasidone's Phase III efficacy in bipolar depression (SCRIP-$)
  • Smith Miller and Patch Inc. et al.; Proposal to Withdraw Approval of 14 New Drug Applications; Opportunity for a Hearing (FDA)
  • Immunogen quits small cell lung cancer study (Pharma Letter-$) (Reuters) (BioCentury) (Fierce)
  • Teva Asks Supreme Court For Stay On MS Drug Patent Ruling (Law 360-$)
  • FDA approves Mylan's generic version of Detrol LA (DSN)
  • FDA approves generic injectable antibiotic (DSN)
  • After Several FDA Setbacks, Idenix To Begin Clinical Study Of New HCV Nuc Outside The U.S. (Pink Sheet-$)

US: Pharmaceuticals and Biotechnology: General

  • Teva's ex-CEO reportedly forced polygraph tests on board to plug media leaks (Fierce) (Pharmalot)
  • Jimmy Carter: Drug makers' generosity good for global society, also boosts PR (Pink Sheet-$) (SCRIP-$)
  • Attention-Deficit Expansion Merits Monitoring: Analysis (Bloomberg)

US: Medical Devices

  • Medical Device User Fee and Modernization Act; Notice to Public of Web Site Location of Fiscal Year 2014 Proposed Guidance Development (FDA)
  • FDA will hold dispute resolution panel for Wright Medical's rejected Augment bone graft (Mass Device)
  • Novocure Announces FDA Approval of the NovoTAL (Transducer Array Layout) System (Press)
  • Intel-GE's Care Innovations gets 510(k) for QuietCare (MobiHealthNews)
  • Gore Receives FDA Approval for 25 cm GORE VIABAHN Endoprosthesis (Press)

US: Dietary Supplements

  • Despite bad publicity, adulteration picture slowly improving, experts say (Nutra-Ingredients)
  • Court tells FDA to stick to food safety rule deadline (The Hill)

US: Assorted And Government

  • Hamburg, Like Industry, Wants Predictability - But In FDA Funding (Pink Sheet-$)
  • PhRMA Says Loophole Allows Plaintiffs To Extract Big Settlements (IHP-$)
  • FDA credibility hurting due to budget issues, commissioner says (Modern Healthcare-$)
  • Regulation Group: ACUS' recommendations to OIRA fall short (CPR)
  • Office of Science Policy, Office of Biotechnology Activities; Recombinant or Synthetic Nucleic Acid Molecule Research: Action Under the NIH Guidelines for Research Involving Recombinant or Synthetic Nucleic Acid Molecules (NIH)

Upcoming Meetings And Events

  • 8 November 2013: Ear, Nose and Throat Devices Panel of the Medical Devices Advisory Committee Meeting (FDA)
  • 13 November 2013: Peripheral and Central Nervous System Drugs Advisory Committee Meeting (FDA)
  • 13 November 2013: Vaccines and Related Biological Products Advisory Committee Meeting (FDA)
  • 14 November 2013: Peripheral and Central Nervous System Drugs Advisory Committee Meeting (FDA)
  • 19 November 2013: Endocrinologic and Metabolic Drugs Advisory Committee Meeting (FDA)
  • 2-3 December 2013: AHWP/RAPS Joint Conference in Malasia (RAPS)
  • 9 December 2013: Joint Meeting of the Gastrointestinal Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee (FDA)
  • 11 December 2013: Meeting of the Endocrinologic and Metabolic Drugs Advisory Committee (FDA)
  • Other Upcoming FDA Advisory Committee Meetings And Topics (FDA)

Europe

Asia

  • Vietnam releases mosquito with bacteria that blocks dengue fever (CBS)
  • Indian Health Ministry still to examine recommendations of Prof Ranjit Roy panel (PharmaBiz)
  • Indian Health ministry fails to make BA/BE studies mandatory after 2 years of proposing (PharmaBiz)
  • Indian govt notifies draft rules on phyto-pharmaceuticals to assess plant-based drugs (PharmaBiz)
  • Japan Modifies Vow For Allowing OTC Drug Sales Via Internet (PharmAsia-$)
  • NuvoLase's PinPointe FootLaser Receives Korean Regulatory Approval (Press)
  • BIOTRONIK PK Papyrus for Acute Coronary Artery Perforations Gets European Approval (MedGadget)
  • Seventh Sense Biosystems Gets CE Mark Approval for Touch Activated Phlebotomy (MedGadget)

Other International

  • Changes to Health Canada's list of recognized standards (Mass Device)
  • Bangladesh's battle with fake and low-standard medicine (IRIN)

Regulatory Reconnaissance #196 - 6 November 2013

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.


Regulatory Focus newsletters

All the biggest regulatory news and happenings.

Subscribe