Regulatory Focus™ > News Articles > Regulatory Reconnaissance (15 March 2013)

Regulatory Reconnaissance (15 March 2013)

Posted 15 March 2013 | By Alexander Gaffney, RAC

Good morning and welcome to another edition of Regulatory Reconnaissance. A slow morning for news if there ever was one, but we still have you well covered.

In the US, the generics industry proposes regulatory solutions to cutting the budget deficit, FDA says it will take time to reclassify painkillers and blames DEA, dozens of citizen petitions ask FDA to speed up ALS drug reviews, KV Pharmaceuticals appeals a court decision over FDA's regulation of Makena, an environmental group slams Congress' oversight of antibiotics regulation, Fresnius receives a warning letter, a Congressional hearing is scheduled on the regulation of medical technologies, robotic surgery manufacturer Intuitive says a policy change is behind rise in AERs, a coalition calls for a regulatory pathway for new sunscreen ingredients, and a rabies case is tracked to a kidney transplant.

Abroad, EMA says it will be able to crunch raw clinical data by 2015, China's SFDA wants companies to do more research on adverse reactions, France calls for regulatory project proposals, MHRA issues guidance on label and leaflet mock-ups, Vanda Pharmaceuticals withdraws its MAA for Fanaptum, Europe's API law has industry panicking, a publishing mistake makes Astellas run afoul of the ABPI code, and China's Vitamin C makers are found to have fixed prices.

Five in Focus:

  1. Don't expect quick action on painkillers, FDA tells lawmakers (The Hill)
  2. KV Pharma Goes After The FDA, Again (Pharmalot)
  3. Fresenius reveals FDA warning letter (Mass Device)
  4. EMA to start crunching raw data (BioCentury)
  5. China's SFDA Urges Drug Firms Do More Research On Adverse Reactions (PharmAsia News) ($)


Sequester & Budget
  • Prescription for Sequestration Pain: Generics Industry Offers Congress Seven Solutions to Save Tens of Bills, Reduce Debt (GPhA)
  • Effects of Budget Uncertainty from Continuing Resolutions on Agency Operations (GAO)
  • Don't expect quick action on painkillers, FDA tells lawmakers (The Hill)
  • Regulatory Innovation and Drug Development for Early-Stage Alzheimer's Disease (FDA/NEJM)
  • Argument preview: Court to write yet another chapter on tort protections for generic pharmaceutical manufacturers (SCOTUS Blog)
  • FDA seeks to fast track Novartis lung cancer drug (Reuters)
  • Dozens of Citizen Petitions Implore FDA to Speed up Drug Regulatory Process for ALS Drugs (Docket)
  • Argument preview: Justices to mull attorney's fees for untimely vaccine claims (SCOTUS Blog)
  • Failure To Update Generic Metoclopramide Label Not Preempted, 6th Circuit Says (Lexis Nexis)
  • KV Pharma Goes After The FDA, Again (Pharmalot)
  • Mylan can launch generic diabetes drug in August (Drug Store News)
  • National Resources Defense Council Slams FDA's Legislative Oversight, Saying Lack of Focus on Antibiotic Resistance is Evidence they are Trying to Hide Something (NRDC)
  • NY Bill Introduced to Make Changes to Registration Process for Wholesalers and Manufacturers or Prescription Drugs (Scout)
  • FDA approves Par generic obsessive compulsive disorder drug (Drug Store News)
  • FDA to review experimental opioid drug (Drug Store News)
  • Matt Yglesias argues the real reason Medicare Part D drug spend has been cheaper than expected is the rate of regulatory approvals (Slate) Counter: Paul Howard (Bloomberg)
  • Report Addresses Antimicrobial Resistance in Food (Food Product Design)
  • Psychiatrists Top List of Big Pharma Payments Again (Medscape)
  • Deadline Approaches For ISPE Drug Shortage Survey (Pharmaceutical Online)
  • Hospira Files Pediatric Written Request for Dexmadetomidine (FDA)
Medical Devices
  • Fresenius reveals FDA warning letter (Mass Device)
  • FDA shakes down Hospira facility in a 3-week inspection (Mass Device)
  • Anti-patent troll bill faces questions in U.S. hearing (Thomson Reuters)
  • Congressional Hearing Scheduled on the Regulation of Health Technologies (Congress)
  • Intuitive blames rise in da Vinci injury reports on policy change (Fierce Medical Devices)
  • Sundance sees future for companion Dx to measure drug-related suicide risk (Fierce Medical Devices)
  • Tandem Diabetes Care wins FDA clearance for new pump software (Mass Device)
  • Phillips Issues Class II Recall to Correct Software Deficiencies (FDA)
  • Obesity startup CEO hopes to be first to bring non-surgical alternative to weight loss in the U.S. (MDDI)
  • Hacking medical devices - movie plot or realistic threat? (Lexology)
  • FDA's proposed rule on foreign clinical studies could affect commercialization plans for medical devices (Lexology)
  • Prospective Grant of Exclusive License: Chimeric West Nile/Dengue Viruses (CDC)
  • FDA Makes Minor Changes to IRB Regulation (FDA)
  • Public Access to Sunscreens Coalition Launches; Calls on FDA to Create Pathway for New, Effective Sunscreen Ingredients to be Accessible to Americans (PASS)
  • Protest over dogs at AstraZeneca (Wilmslow Express)
  • New York Introduces Bill to Regulate Dietary Supplements (Scout)
  • New York Bill Requiring Supplements to Label Products With "Not tested by FDA" Clears Committee (Scout)
  • Human Corneas Recalled After Donor Eligibility Wasn't Tested (FDA) (Class III)
  • Blood Products Recalled After Donors Were not Physically Examined (FDA) (Class II)
  • Navidea drops after FDA nod for drug used in cancer patients (Fierce Biotech)
  • New Government Rules Would Restrict Agency Growth of Federal Properties and Facilities (OMB)
  • Maryland rabies case came from kidney transplant, sources say (Washington Post)
  • Two Plead Guilty to Participation in International Conspiracy to Import and Distribute Prescription Drugs and Anabolic Steroids (FDA)
  • FDA to Continue to Fund Cross-Species Immune System Reference Study on Medical Countermeasures (FDA)


  • EMA to start crunching raw data (BioCentury)
  • China's SFDA Urges Drug Firms Do More Research On Adverse Reactions (PharmAsia News) ($)
  • France Issues Call for Regulatory Project Proposals (ANSM)
  • France to Establish Committee Composed of Regulators and Patient Associations (ANSM)
  • MHRA Guidance on submitting label and leaflet mock-ups following variations (MHRA)
  • Vanda Pharmaceuticals Ltd withdraws its marketing authorisation application for Fanaptum (iloperidone) (EMA)
  • Symbio and Eisai Announce Removal of Treakisym Injection 100 mg All Cases Surveillance Condition for Japan Marketing Approval (Eisai)
  • EU API law has drugmakers there in panic (Fierce Pharma Manufacturing)
  • World API Market Growth Slows, CPA Report Finds (Outsourcing Pharma)
  • Publishing mix up leads to Astellas Code breach (Pharma Times) (Pharmafile)
  • And Then There Were Eight: the 2013 Revision of EU Vigilance Guidelines for Medical Devices (Medtech Insider)
  • Sinovac vaccine meets primary in Phase III trial (BioCentury) (Reuters) (BioSpectrum)
  • India's Claris Viewed Takeover Target Because Of U.S. Injectables Shortage (PharmAsia News) ($)
  • Chinese Vitamin C Makers Fixed Prices, U.S. Jury Says (Bloomberg)


  • Surgery clinical trial results selectively reported (Reuters)
  • GlaxoSmithKline boss says new drugs can be cheaper (Reuters)
  • Tired of explaining the process of drug development to people? NIH has a YouTube video you might enjoy (NIH)
  • Transgenic Goats Producing Human Breast Milk Enzyme May Help Stop GI Infections Wordwide (Medgadget)
  • Does Baldness Get More Funding Than Malaria? (In the Pipeline)
  • Rapid HIV treatment points to "functional cure" for AIDS (Reuters)
  • Stem cells transplantation technique has high potential as a novel therapeutic strategy for ED (EurekAlert)
  • Pee in a cup to diagnose gastroesophageal cancer (Fierce Biomarkers)
  • China's Cultural Approach to Safety Leaves Something to be Desired (Marginal Revolution)

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 or @AlecGaffney 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.

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