Regulatory Focus™ > News Articles > Regulatory Reconnaissance (11 April 2013)

Regulatory Reconnaissance (11 April 2013)

Posted 11 April 2013 | By Alexander Gaffney, RAC

Good morning and welcome to another edition of Regulatory Reconnaissance.

In the US, a cat results in a company getting a Form 483, a NIH study of premature infants is blasted as unethical, a state shelves biosimilar legislation, Bayer sues FDA to block a generic of its drug Baytril, a PDUFA date for Delcath is pushed back, yet another compounding pharmacy recalls all its products, a TB drug shortage is partially resolved, Mylan comments on a lawsuit by Apotex, Stryker initiates a class I recall, Tufts says new protocol approaches will lead to improved trial performance and efficiency, OIRA clears six FDA documents, the House committee overseeing FDA gets a new member, and legislation set to be marked up in the House Committee on the Judiciary would subject regulations to congressional review.

Abroad, India's CDSCO will serve as the competent authority for issuing certificates of export to meet new EU API requirements, St. Jude wins a CE mark for its Dystonia brain implant, CDSCO forms a new international affairs office and reorganizes its regulatory activities, NICE greenlights Lucentis, Abbott's diagnostic gets a CE mark, the UK eases restrictions on Sativex, Health Canada adopts an ICH guideline on PBRERs, and Eisai plans to use a sliding scale of discounts to help it access India's drug market.

Plus: Teva looks to start-ups to help it solve regulatory problems.

Five in Focus

  1. Watchdog agency criticizes ethics of study of premature infants (Washington Post) (NYTimes) (Public Citizen)
  2. Cat on Premises Helps Land Devicemaker a Form 483 (FDA News) ($)
  3. India's MHFW Confirms that CDSCO Will Act as Competent Authority for API Exports to EU (CDSCO)
  4. St. Jude wins European OK for brain implant to treat Dystonia (Med City News) (MDDI) (Reuters) (Mass Device)
  5. Another Compounding Pharmacy Issues Recall for all Sterile products Due to Sterility Concerns (FDA)


  • Another State Smacks Down Biosimilar Legislation (Pharmalot)
  • Amid cheers and jeers, GlaxoSmithKline reveals Duchenne drug hit PhII goal (Fierce Biotech)
  • Bayer Sues FDA Seeking to Block Sales of Generic Baytril (Bloomberg)
  • FDA delays PDUFA for Delcath's chemosaturation system (BioCentury)
  • Another Compounding Pharmacy Issues Recall for all Sterile products Due to Sterility Concerns (FDA)
  • Manufacturers Partially Resolve US TB Drug Shortage, No Official Word from FDA, CDC (In-Pharma Technologist)
  • Mylan Blasts Apotex Challenge To Generic Benicar Exclusivity (Law 360) ($)
  • Office of Compliance and Biologics Quality (OCBQ) Updates its Webpage (FDA)
  • Analysts rank the top 10 blockbuster duds in biopharma (Fierce Biotech)
  • FDA Presentations from the Workshop on Innovations in Breast Cancer Drug Development - Neoadjuvant Breast Cancer are now Posted (FDA)
  • Affirm XL, Inc Issues a Voluntary Nationwide Recall of Affirm XL Dietary Supplement Tablet, Lot 1190001 Due to Potential Health Risk (FDA)
  • CDER MAPP: Authorization and Tracking of Outside Speaker Clearance (FDA)
  • User Fee Management System Part Of CDER Plans To Enhance IT Capabilities (The Pink Sheet) ($)
  • Merck Announces FDA Acceptance of New Drug Application for an Investigational Tablet Formulation of the Antifungal NOXAFIL (posaconazole) (Merck)
  • Acadia Plans Early FDA Filing Of Parkinson's Drug (The Street)
Medical Devices
  • Cat on Premises Helps Land Devicemaker a Form 483 (FDA News) ($)
  • Class I Recall: Stryker's Shapematch Cutting Guides Recall as Class I Recall (FDA)
  • Mobisante launches Windows tablet-based, FDA-cleared ultrasound system (Mobi Health News)
  • Class I Recall: Respironics SealFlex Single Port Ribbed Mask (Infant) (FDA)
  • Calgary Scientific's ResolutionMD Android imaging app wins FDA nod (Mass Device)
  • FDA accepts Edap's Ablatherm PMA application (Mass Device)
  • Watchdog agency criticizes ethics of study of premature infants (Washington Post) (NYTimes) (Public Citizen)
  • New Protocol Design Approaches Will Improve Clinical Trial Performance And Efficiency, According To Tufts Center For The Study Of Drug Development (Medical News Today)
  • Doctors not informed of harmful effects of medicines during sales visits (EurekAlert)
  • Oregon moves forward on a new bill to regulate academic detailing (Scout)
  • OIRA Signs off on ADUFA, Medical Device Inspections, Device Detention, Medical Device User Fee Cover Sheet, Supplement Guidance, IVD Guidance (OIRA)
  • Patent Medicines Get A Belated Chemical Checkup (NPR)
  • Federal Judge Grants Defendants' Motion for Summary Judgment in "All Natural" Lawsuit (FDA Law Blog)
  • FDA Enforcement Report - Week of April 10, 2013 (FDA)
Government and Budget
  • Energy and Commerce Committee Appoints Cathy McMorris Rodgers back to the Health Subcommittee (E&C)
  • Full Committee Markup of: H.R. 367, the "Regulations From the Executive in Need of Scrutiny Act of 2013" (Committee on the Judiciary)
  • Raising Part D Donut Hole Discounts To 75% Proposed By President (The Pink Sheet Daily)
  • Biopharma lobbyists slam Obama budget as 'bad for innovation' (SCRIP Intelligence)
  • On left and right, Obama's budget anticipated as a dud (Federal Times)
  • FDA FY 2014 Budget Request Suggests Confidence In BsUFA Revenue (The Pink Sheet) ($)
  • Obama's $3.7T Spending Plan Would Cut $370B From Medicare (Kaiser Health News)
Meetings and Events This Week
  • 8 April 2013: Ophthalmic Devices Panel of the Medical Devices Advisory Committee Meeting Announcement (FDA) (Meeting Materials)
  • 9 April 2013: Congressional Hearing: Reauthorization of Animal Drug User Fees: ADUFA and AGDUFA (E&C) (FDA Testimony)
  • 10 April 2013: Public Workshop: Application of Advances in Nucleic Acid and Protein Based Detection (FDA)
  • 11 April 2013: Device Good Manufacturing Practice Advisory Committee Meeting Announcement (FDA) (Meeting Materials)
  • 17 April 2013: Cellular, Tissue and Gene Therapies Advisory Committee Meeting (FDA)
  • Other Upcoming FDA Advisory Committee Meetings and Topics (Eye on FDA)


  • India's MHFW Confirms that CDSCO Will Act as Competent Authority for API Exports to EU (CDSCO)
  • India's CDSCO Announces Re-Prioritization of Regulatory Activities (CDSCO)
  • CDSCO Forms an International "Cell" Office (CDSCO)
  • St. Jude wins European OK for brain implant to treat Dystonia (Med City News) (MDDI) (Reuters) (Mass Device)
  • NICE Nod To Lucentis For ME Raises Unlicensed Comparator Issue (The Pink Sheet) ($) (BioCentury) (PMLive) (Pharma Times)
  • Abbott/BG heart failure Dx gains CE mark (Fierce Medical Devices)
  • Japanese Regulatory Reform Committee Proposes Early Approval Plan For iPS Regenerative Medicine (PharmAsia News) ($)
  • TGA presentations given at the CHC regulatory obligations seminar, 18 March 2013 (TGA)
  • Reclassification of hip, knee and shoulder implants: Letter to sponsors and regulatory consultants (TGA)
  • Eisai Sets Sliding-Scale Discounts For India Launch Of Breast-Cancer Drug (PharmAsia News) ($)
  • Lilly CEO Presses China For Favorable Environment For Innovative Drugs (PharmAsia News) ($)
  • UK Home Offices eases restrictions on GW's Sativex (Pharma Times)
  • Sanofi says authorities to assess new flu vaccine (Reuters)
  • Health Canada Adopts ICH E2C(R2) on PBRERs (Health Canada)
  • What's cooking at IMDRF? UDI and software, among other things (Medical Devices Legal)

General Regulatory and Interesting Articles

  • How Much Does It Hurt? Let's Scan Your Brain (NPR)
  • Natural versus Synthetic Chemicals Is a Gray Matter (Scientific American)
  • Wireless Charging System to Power Hungry Medical Implants (MedGadget)
  • Teva is looking for a few good entrepreneurs for a global drug launch platform (Med City News)
  • Brains as Clear as Jell-O for Scientists to Explore (NYTimes)
  • Does Biopiracy rips off native medical knowledge? (DW)
  • Infect mosquitoes with Wolbachia, stop diseases (BioSpectrum)
  • Microbes Can Mass-Produce Malaria Drug (MIT Technology Review)
  • Study finds no fertility drug, ovarian cancer link (Reuters)
  • Currently Approved Drugs Found Effective in Laboratory Mice Against Bioterror Threats (EurekAlert)

Regulatory Reconnaissance #43 - 11 April 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.

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Need to contact the editor of Regulatory Reconnaissance? Find him on Twitter at @AlecGaffney or send him an email at

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