Regulatory Focus™ > News Articles > Regulatory Reconnaissance (2 May 2013)

Regulatory Reconnaissance (2 May 2013)

Posted 02 May 2013 | By Alexander Gaffney, RAC

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.

In Focus: US

  • FDA Seeks Think Tank Help On Opioid Drug Trials (Pharmalot)
  • Novartis Hit With Four FDA Form-483s (FDA)
  • Uniform GMPs for Excipients Coming Soon (FDA News) ($)
  • Christy Foreman: FDA Guidance on Mobile Apps and Devices Should be Out by October 2013 (Healthcare IT News) (Politico)
  • FDA Spending Feels Sequester's Pinch As Program Managers Finalize FY '13 Plans (The Pink Sheet) ($)

In Focus: International

  • Docs Down Under Agree To Greater Disclosure Of Pharma Ties (Pharmalot)
  • EMA: disclosure policy 'will not impinge IP rights' (SCRIP Intelligence)
  • AllTrials Campaign: European Court is on the wrong side on patient safety (AllTrials)
  • USTR To India: Access to medicine and innovation not mutually exclusive (India Times)
  • Indian Parliamentary Panel Demands Health Ministry Speed up Evaluation of Suspect Drugs (PharmaBiz)

Comments? Suggestions? Shoot me an email at news@raps.org.

US

Pharmaceuticals/Biotechnology
  • FDA Seeks Think Tank Help On Opioid Drug Trials (Pharmalot)
  • J&J grabs another 'breakthrough' FDA win with early-stage cancer drug (Fierce Biotech) (J&J) (Bloomberg) (RTT) (The Pharma Letter) ($)
  • Amgen Drugs May Boost Survival During a Nuclear Attack (Bloomberg) (FDA) (Reuters) (SCRIP Intelligence)
  • FDA cautions against antibiotics for heart patients (NBC)
  • New Jersey Is Paid $600,000-Plus from Separate Settlements Resolving Allegations of Wrongdoing by Two Pharmaceutical Manufacturers (OIG)
  • New York Settled With Amgen for $11 Milion Over Purported Medicaid Fraud (NY)
  • FDA Releases Four Novartis 483s (FDA)
  • Uniform GMPs for Excipients Right Around the Corner (FDA News) ($)
  • AbbVie, Teva Hit With 2 More Niaspan Pay-For-Delay Suits (Law 360) ($)
  • FDA pressed to go further on Plan B (The Hill) (Reuters)
  • Allergan slams brakes on two key PhIIIs after data disappoints (DDDMag) (Reuters) (Pharma Times) (BioCentury) (Fierce Biotech)
  • NYTimes Editorial Board: Prices Paid for Leukemia Drugs are "Exorbitant" (NYTimes)
  • Key trial of Seaside autism drug fails to show benefit (Reuters)
  • Forest Laboratories and Almirall Announce Positive Results for the Second Phase III Study for Aclidinium and Formoterol combination in COPD (Forest)
  • Impax Says it Will Cost $10-15 Million to Comply With FDA Form 483 Letter (Impax)
  • AMRI Exec Discusses 'New Bar' in FDA Enforcement (Outsourcing Pharma)
  • Judge Nullifies Verdict in Takeda Actos Drug Case (Takeda)
  • KV Pharma Can't Duck Securities Suit Over FDA Woes (Law 360) ($)
  • High Court Asked To Review 2nd Circ. Fosamax Ruling (Law 360) ($)
  • US court throws out first Actos verdict (SCRIP Intelligence) ($)
  • Novartis Stresses FDA Approvals In Zometa Trial (Law 360) ($)
  • FDA delays GSK trametinib NDA by 3 months (SCRIP Intelligence) ($)
  • FDA Approves Efficacy Supplement for AstraZeneca's Seroquel and Seroquel XR (FDA)
  • FDA Approves ANDAs for Aurobindo's Clindamycin Palmitate HCl (#202409), Autrobindo's Tamsulosin HCl (#202433), Heritage Pharmaceutical's Doxycycline Hyclate (#200856), Emcure Pharmaceutical's Adenosine (Tentative, #202313), and Alembic Pharmaceutical's Valsartan (Tentative, #091367). (FDA)
Medical Devices
  • Christy Foreman: FDA Guidance on Mobile Apps and Devices Should be Out by October 2013 (Healthcare IT News) (Politico)
  • Hips: Bellwether federal trial against DePuy delayed (Mass Device)
  • FDA Looking to Buy a Stents-Lots and Lots of Stends (FDA)
  • V8 Aortic Valvuloplasty Balloon Catheter FDA Cleared (Med Gadget)
  • Meetings: Gastroenterology and Urology Devices Panel of Medical Devices Advisory Committee to Meet on Reclassification of sorbent hemoperfusion systems (FDA)
  • OMB Approval of FDA's Inspection by Accredited Persons Program (FDA)
  • Class 1 Recall: Medtronic's DBS Dystonia Therapy Kit Due to Potential Lead Damage (FDA)
  • Class 1 Recall: Medtronic's Deep Brain Stimulation Lead Kit because of potential lead damage (FDA)
  • Newport Medical Instruments, Inc., HT70 and HT70 Plus Ventilators: Class I Recall - Unit Goes Into Internal Backup Battery Sooner Than Expected (FDA) (FDA)
Assorted
  • FDA Spending Feels Sequester's Pinch As Program Managers Finalize FY '13 Plans (The Pink Sheet) ($)
  • Fewer Letters, Fewer Warning Letters (Eye on FDA)
  • Using Scientific Literature in Food or Dietary Supplement Marketing? Proceed with Caution (FDA Law Blog)
  • Warning letters show companies still vague on nature of website language (Natural Products Insider)
  • Supplement Adulteration, GMPs Top FDA Watchlist (Natural Products Insider)
  • New Internet Domain Name .PHARMACY Will Foster Patient Safety (Safe Medicines)
  • FDA Enforcement Report for Week of 1 May 2013 (FDA123)
  • OMB Signs off on "Electronic Submission of FDA Adverse Event Reports and Other Safety Information Using the Electronic Submission Gateway and the Safety Reporting Portal" (OMB)
  • Call for Comment: Product Jurisdiction; Assignment of Agency Component for Review of Premarket Applications (FDA)
  • FDA Ignores Toxic Arsenic In Animal Feed, Suit Says (Law 360) ($)
  • Physician Payment Sunshine Act: Principal Investigators and Primary Care Physicians Largely Unaware of Regulation (Policy and Medicine)
  • The Next 'Killer App' To Cut Health Care Costs: Getting Patients To Take Their Meds (Forbes)
  • Cargo thefts spike as robbers target pharmacy deliveries (Fierce Pharma Manufacturing)
Government and Budget
  • Opinion: Big Pharma Accomplishes Big Things, Yet Obama Is Suffocating The Industry (Forbes)
Upcoming Meetings and Events
  • 29 April 2013: Accessible Medical Device Labeling in a Standard Content and Format (FDA)
  • 29 April 2013: Meeting of the Risk Communication Advisory Committee (FDA)
  • 29 April 2013: Margaret Hamburg to Appear at Milken Institute Conference on 'The Promise of the Bioscience Century' (Milken)
  • 30 April 2013: Meeting of the Risk Communication Advisory Committee (FDA)
  • 2 May 2013: Meeting of the Oncologic Drugs Advisory Committee (FDA)
  • 2 May 2013: Meeting of the General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee (FDA)
  • 3 May 2013: Joint Meeting of the Medical Imaging Drugs Advisory Committee and Oncologic Drugs Advisory Committee (FDA)
  • 16 May 2013: OPDP Enfocement Actions Webinar (FDA)
  • Other Upcoming FDA Advisory Committee Meetings and Topics (FDA)

International

  • Docs Down Under Agree To Greater Disclosure Of Pharma Ties (Pharmalot)
  • EMA: disclosure policy 'will not impinge IP rights' (SCRIP Intelligence)
  • EMA Guideline on the acceptability of names for veterinary medicinal products processed through the centralised procedure (EMA)
  • China's CFDA issues the First Summary of Announcements of Illegal Drug, Medical Device, and Health Food Advertisements in 2013 (CFDA)
  • AllTrials Campaign: European Court is on the wrong side on patient safety (AllTrials)
  • Indian Parliamentary Panel asks Health Ministry to Reduce Deadline Given to Prove Efficacy, Safety of FDCs (PharmaBiz)
  • Access to medicine and innovation not mutually exclusive: USTR (India Times)
  • MHRA issues warning about FreeStyle InsuLinx blood glucose meter (MHRA)
  • Pharmexcil signs MoUs with international organisations to boost exports of affordable, safe medicines (PharmaBiz)
  • Inquiry sought into recall of one batch of pentavalent vaccine from market by manufacturing co (PharmaBiz)

General Regulatory and Interesting Articles

  • Venture Capitalist: Electricity Therapy is Like a Drug in the Device World With Potentially Little to No Side Effects (Mass Device)
  • Oncology trials may lack rigour, find Duke researchers (Pharma Times)
  • Hidden Cancer Risks for Women Found in Genome Analysis (Bloomberg)

Regulatory Reconnaissance #58 - 2 May 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.


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