Regulatory Focus™ > News Articles > Regulatory Reconnaissance (13 March 2013)

Regulatory Reconnaissance (13 March 2013)

Posted 13 March 2013 | By Alexander Gaffney, RAC 

Good morning and welcome to another edition of Regulatory Reconnaissance. The good news: FDA stands to gain access to new user fees under both proposed House and Senate budget bills. The bad news: No one is sure if they can actually pass in time to avoid a government shutdown.

In the US, FDA has completed work on its animal user fee bills, FDA wins a court case against Hill Dermaceuticals, new warnings letters are out, Stryker hit with an as-yet unpublished warning letter, legislators plan to hold a hearing on the regulation of mobile apps, OIRA seems to be on autopilot and a proposed bill could make FOIA requests a whole lot easier.

Abroad, Chinese regulators look to reduce the number of illegal drug ads, Indian clinical trials deaths plummet, a UK man is found guilty of manipulating research data, India's industry looks to clarify GDP guidelines, Australia and New Zealand are out with new OTC reforms, and a SARS-like virus continue to terrify public health officials.

Five in Focus:

  1. CVM Completes Work on Two Animal Drug User Fee Programs (FDA)
  2. FDA warns Stryker on quality issues, marketing practices (Reuters) (Fierce Medical Devices) (Mass Device)
  3. Committee Announces Three Day Hearing Series on Health Information Technology to Explore Potential Regulations and Taxes on Smartphones, Tablets and Mobile Apps (E&C)
  4. Chinese Regulators To Jointly Crackdown On Illegal Medicines Ads (PharmAsia News) ($)
  5. UK Man found guilty of manipulating preclinical drug tests for CRO (Financial Times) (Pharmafile)

US

Sequester & Budget
  • Senate budget bill includes user fees (BioCentury)
  • Medicare would negotiate drug prices under Dem bill (The Hill)
Pharmaceuticals/Biotechnology
  • CVM Completes Work on Two Animal Drug User Fee Programs (FDA)
  • Hill Dermaceuticals v. FDA Decided in Favor of FDA Based on Hill's Unsubstantiated, "Hyperbolic" Claims (DC 9th Circuit)
  • FDA slaps vaginal gel maker for sloppy manufacturing, no NDA (Fierce Pharma Manufacturing)
  • Wary of Attack With Smallpox, U.S. Stockpiles a Costly Drug (NYTimes)
  • FDA's New Neonatology Panel To Discuss Challenges In Study Design, Conduct (The Pink Sheet Daily)
  • Swine-Flu Vaccines Carry Slight Risk of Rare Disease (Bloomberg)
  • Merck Hid Fosamax's Bone-Weakening Risks, Lawyer Contends (Bloomberg)
  • FDA OKs Ampio Trial (Drug Discovery and Development)
  • Safety Board Clears Merck's Vytorin Trial to Continue (WSJ) (Reuters)
  • California Lawmakers Want State Medical Board To Mine CURES Data (California Healthline)
  • Bayer Joins Merck in Fighting Generic Drugs Case (Bloomberg)
  • Another Skirmish in the Preemption War: Does FDA Approval Trump Strict Liability? (CPR Blog) (SCOTUS Blog)
  • Niacin, Statins And Difficulties Of Drug Discovery (Forbes)
  • Upcoming FDA Webinar Tuesday, March 19th - Buyer Beware:The Risks and Dangers of Purchasing Drugs Online (FDA)
  • FDA Closes out Citizen Petition on Desloratadine Due to Inactivity (Federal Register)
  • FDA Calls for Safe Disposal of Fentanyl Patches (FDA)(FDA)
Medical Devices
  • FDA warns Stryker on quality issues, marketing practices (Reuters) (Fierce Medical Devices) (Mass Device)
  • Committee Announces Three Day Hearing Series on Health Information Technology to Explore Potential Regulations and Taxes on Smartphones, Tablets and Mobile Apps (E&C)
  • Are All Health and Wellness Mobile Apps Exempt from FDA Regulatory Requirements? (FDA Law Blog)
  • Metal hip trial reveals ethical dilemma for plaintiffs' lawyers (Thomson Reuters)
  • New video game detects vision problems in children (Fox News)
  • Medical Device Manufacturer Annex Medical Asks 8th Circuit To Reverse Decision In Birth Control Mandate Suit (Lexis Nexis)
  • New MITA Smart Dose Standard Enhances Dose Optimization and Management in CT Equipment (MITA)
  • Once Banned, Silicone Breast Implants Make a Comeback (WSJ)
Warning Letters
  • (Pharmaceutical) Laclede Inc for Significant CGMP Violations Causing its Prebiotic Vaginal Moisturizer and Lubricant Product to be Adulterated (FDA)
  • (Medical Device) Hoissen Inc for CGMP Deficiencies Relating to its Dental Implant Products (FDA)
  • (Medical Device) Dermaroller GmbH for Marketing an Unapproved Device Without a PMA/510(k) (FDA)
  • (Medical Device) Grantech Co. for QSR violations related to its thermometer device (FDA)
  • (Medical Device) CoRE Labs LLC for MDR, DMR, QSR violations related to its Flora Wall Bucky Stands and Atlas Radiographic Tables (FDA)
  • (Dietary Supplement) Organics Corporation of America for CGMP Violations Related to Testing Procedures for Several Products (FDA)
  • (Medical Device/IVD) Amresco for quality and validation procedures related to the manufacture of reagents (FDA)
  • (Medical Device) VE Valley Electronics GmbH for misbranding several fertility devices and various quality deficiencies (FDA)
  • (Medical Device) Linet Spol S.r.o. for misbranded hospital beds, MDR/DHR deficiencies (FDA)
Assorted
  • DoJ and GMPs: A Prosecutor's Take on Enforcing Product Quality (RPM Report)
  • White House regulatory office on autopilot? (The Hill)
  • Business presses feds to dive deeper into costs of new regs (The Hill)
  • Transparency Bill Would Create Portal for U.S. Records Requests (Bloomberg)
  • Meetings: Food and Drug Administration/Xavier University Global Medical Device Conference (FDA)
  • Dollars for Docs: The Top Earners (ProPublica)
  • Night Bullet: Recall - Undeclared Drug Ingredient (FDA)
  • New Amicus Brief Filed in the Supreme Court in the Myriad (Gene Patent) Case (Harvard Bill of Health)
  • Former Office of Information and Regulatory Affairs Administrator Paints Unrecognizably Rosy Picture of Rule Reviews (Center for Effective Government)
  • A Clinical Trial and Suicide Leave Many Questions: Part 5: The Case of the Mysteriously Appearing Documents (Scientific American)
  • Judge Rules the Government May Legally Serve Documents Through Facebook. Could a Warning Letter be Next? (Thomson Reuters)
  • Request for Information on the FY 2013-2018 Strategic Plan for the Office of Disease Prevention (NIH)

International

  • UK says pharma needs incentives for antimicrobial drug research (PM Live)
  • Chinese Regulators To Jointly Crackdown On Illegal Medicines Ads (PharmAsia News) ($)
  • Number of Active Investigators Worldwide Reaches an All-time High (Tufts CSDD)
  • Deaths during clinical trials come down considerably during last two years (PharmaBiz)
  • UK Man found guilty of manipulating preclinical drug tests for CRO (Financial Times) (Pharmafile)
  • Novartis Withdraws Gleevec Application For Pulmonary Arterial Hypertension in Japan (PharmAsia News) ($)
  • Clinical trials for medicines: Risk adapted approaches to management of clinical trials (MHRA)
  • Annexes to: CPMP/ICH/283/95 Impurities: Guideline for residual solvents & CVMP/VICH/502/99 Guideline on impurities: residual solvents (EMA)
  • European Society of Cardiology responds to European Commission's Proposals for new regulation to govern medical devices (ESC) 
  • Chemistry group urges India's health ministry to rectify anomalies in GDP guidelines (PharmaBiz)
  • Indian Biotech industry assn plans to join case on clinical trials in Supreme Court (PharmaBiz)
  • Manufacturing group calls on Indian regulators to establish regulatory nowms for raw materials quality for natural products (PharmaBiz)
  • CVD data to be standardised across Europe  (ESC)
  • AUS/NZ Over-the-counter (OTC) medicines business process reform: Key points (TGA)
  • AUS/NZ Over-the-counter (OTC) medicines business process reform: Outcome of consultation (TGA)
  • Update on TGA decision to cancel prescription pain-killers (TGA)
  • Death toll from new SARS-like virus climbs to 9 (CNN)
  • Astellas Submits Application for Marketing Approval of Ipragliflozin (ASP1941), SGLT2 Inhibitor for Treatment of Type 2 Diabetes, in Japan (Astellas)

Interesting

  • Risk-Based Algorithm Could Ease Monitoring of Clinical Trials, Report Says (Outsourcing Pharma)
  • Too many drug types are compromising heart health: doctors (Reuters)
  • GlaxoSmithKline and Roche won't disclose their results (BMJ)
  • Navigating Human Factors Validation Studies (MDDI)
  • Resistance From C-Suite Sours the Job for Some Compliance Officers; Board Intervention May Help (AIS Health)
  • Real World Data: Medical Device and Diagnostics Perspectives (Eye for Pharma)


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.


Regulatory Focus newsletters

All the biggest regulatory news and happenings.

Subscribe