Regulatory Focus™ > News Articles > Regulatory Reconnaissance (1 March 2013)

Regulatory Reconnaissance (1 March 2013)

Posted 01 March 2013 | By Alexander Gaffney, RAC

Good morning and welcome to another edition of Regulatory Reconnaissance. The sequester starts at 11:59 p.m. tonight, but BioCentury is reporting that the White House is lobbying Congress to pass legislation exempting FDA's user fees from the cuts. Will they listen?

In the US, regulators approve a once-monthly version of Abilify, FDA looks favorably on two hot flash drugs, a prominent lawyer says FDA's new recall guidance is bunk, FDA is investigating surgical robot systems, and two new pieces of legislation seek to put curbs on regulation.

Abroad, EMA is out with six new scientific guidance documents, the EU has earmarked €144 million for rare disease research, Medtronic has received a CE mark for its Engager Transcatheter Valve, and the EC has appointed patient representatives to the PRAC.

Five in Focus:

  1. White House to Congress: Take FDA's User Fees out of the Sequester (BioCentury)
  2. Shapiro: FDA Recall Guidance Creates Reporting Requirement Not Authorized by Law, In Serious Need of Overhaul (FDA Law Blog)
  3. FDA Seeks Data on Surgical Robots, Including da Vinci Surgical System (WSJ)
  4. EU approves Novartis drug for gout (Reuters)
  5. €144 million earmarked for new research on rare diseases (EuroActiv) (European Commission) (Pharma Times)




  • FDA pins approval on once-monthly version of blockbuster Abilify (Fierce Biotech) (Otsuka) (Reuters)
  • FDA staff say two non-hormonal hot flashes drugs show some efficacy (Reuters) (Pink Sheet Daily)
  • Industry, Patient Groups Comment on Cellular and Gene Therapy Products Guidance (BIO) (JDRF) (AABB) (ISCT)
  • Takeda Didn't Warn of Actos Cancer Risk, Lawyer Says (Bloomberg)
  • The Confusion Over A Pair Of Diabetes Drugs And Pancreatitis (Forbes)
  • CDER's Charles Ganley Out of Office Indefinitely (FDA Webview) ($)
  • Biotechs adopt orphan drugs (Boston Herald)
  • Washington Legal Foundation to SCOTUS: Reject Patent Settlement Challenge (WLF)
  • Sunovion seeks FDA approval for epilepsy drug (Boston Herald)
  • FDA Grants Petition Allowing Generics to use Medefil's Sodium Chloride Injection as RLD (Federal Register)
  • FDA Finds that Differin (Adalpalene) Solution Was Voluntarily Withdrawn Not For Reasons of Safety or Effectiveness (Federal Register)
  • Glaxo DMD Drug Tied to Serious Side Effects, Hospitalizations (The Street)
  • PhRMA Statement on Proposal for an Alternative Approval Pathway for Certain Drugs Intended to Address Unmet Medical Need (PhRMA)
  • Merck's Tredaptive fiasco blamed on adverse reactions to niacin (Fierce Biotech)
  • Diabetes drugs tied to pancreatitis: study (Med City News)
  • The Regulatory Pendulum Swings In Favor Of Antibiotics, But Will Investments Follow? (Start-Up) ($)
  • Reps. Waxman and Slaughter Introduce Legislation to Better Monitor Antibiotic Use in Animals (E&C) (FDA Law Blog) (Pharmalot)
  • Study on the Structural Roots of Drug Shortages and The Shortages Effects on Kids (Policy and Medicine)
  • QRxPharma resubmits Moxduo NDA to US FDA (BioSpectrum)
  • FDA Grants QIDP And Fast Track Designations For Cubist's Late-Stage Antibiotic Candidates (Pharmaceutical Online)
  • Boehringer targets AML with new Phase III study (Pharmafile)
  • Pharmaceutical companies: An $84 million marketing effort in the District of Columbia (EurekAlert)
  • Cymbalta still tops in U.S. drug promotion list (MedAdNews)

Medical Devices

  • FDA Seeks Data on Surgical Robots, Including da Vinci Surgical System (WSJ) (Bloomberg)
  • Trial plaintiff says J&J hips defective, company says not liable (Reuters)
  • Shapiro: FDA Recall Guidance Creates Reporting Requirement Not Authorized by Law, In Serious Need of Overhaul (FDA Law Blog)
  • Jury awards woman $7.76 million in damages for J&J mesh (Reuters)
  • FDA Issues Warning Letter To CoreValve Investigator (Forbes)
  • Second insulin-pen lawsuit is announced in Western New York (Buffalo Business First)
  • Trade group identifies medical device makers passing on federal tax (Reuters)
  • The security risks of medical devices (Mass Device)
  • FDA Approves Novel ICD Device Made by Biotronik. But will the Company Win Share in the U.S.? (MD+DI Online)
  • Minimum Clinically Important Difference, Outcome Metric in Orthopaedic Device, November 27, 2012 - Transcript (Federal Register) (Day Two)
  • Societies Rate Cardiac Device Use (Medpage Today)


  • H.R.309 - Regulatory Sunset and Review Act of 2013 (Congress)
  • H.R.315 - Synthetic Cathinones Control Act of 2013 (Congress)
  • H.R.367 - Regulations From the Executive in Need of Scrutiny Act of 2013 (Congress)
  • Rare Disorders Without Borders: An International Strategy (FDA)
  • Public Citizen President to Congress: Regulatory Benefits Vastly Exceed Costs (Public Citizen)
  • Clinical Trials Transformation Initiative (CTTI) Forms Patient Leadership Council to Help Drive Improvements in Clinical Trials (National Clinical Trial Network)
  • HHS Awards Contract for Development of Novel Flu Treatment (Biopharm International)


  • Guideline on the use of porcine trypsin used in the manufacture of human biological medicinal products (EMA)
  • Guideline on the clinical investigation of medicinal products for the treatment of Duchenne and Becker muscular dystrophy (EMA)
  • Concept paper on the need for revision of note for guidance on clinical investigation of medicinal products for the treatment of cardiac failure (EMA)
  • Concept paper on use of recovered/recycled solvents in the manufacture of herbal preparations for use in herbal medicinal products / traditional herbal medicinal products (EMA)
  • Reflection paper on quality of essential oils as active substances in herbal medicinal products/traditional herbal medicinal products (EMA)
  • Concept paper on the need to revise the guideline on the clinical development of fixed dose combinations of medicinal products regarding dossier content requirements (EMA)
  • EU approves Novartis drug for gout (Reuters)
  • EMA Bulletin on 2012 Veterinary Pharmacovigilance Activities (EMA)
  • European Commission Decision Appointing Members and Alternates of the PRAC to Represent Healthcare Professionals and Patient Organizations (EudraLex)
  • €144 million earmarked for new research on rare diseases (EuroActiv) (European Commission) (Pharma Times)
  • Canada to fund non-nuclear sources for medical isotopes (Reuters)
  • India's small pharma exporters urge govt not to make 2D bar code mandatory (PharmaBiz)
  • Medtronic Announces CE Mark for Engager Transcatheter Valve (Medtronic) (Fierce Medical Devices)
  • Lundbeck gets EU nod for new drug to fight alcohol addiction (Fierce Biotech)
  • Japan To Speed Approval Process For Academically Developed Drugs (PharmAsia News) ($)
  • Roche says it will not relinquish control over access to clinical trial data (BMJ)
  • Japan approves broader indication for Lyrica (BioSpectrum)
  • Orphanet Report on Disease Registries in Europe (Orphanet)


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 meaning intelligence newsletter here.

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