Regulatory Focus™ > News Articles > Regulatory Reconnaissance (18 March 2013)

Regulatory Reconnaissance (18 March 2013)

Posted 18 March 2013 | By Alexander Gaffney, RAC 

Good morning and welcome to another edition of Regulatory Reconnaissance. Industry giant Dr. Anji Reddy, founder of generic manufacturer Dr. Reddy's and widely seen as the father of the Indian generics industry, has died.

In the US, four drugs await approval decisions in the next 30 days, compounding pharmacies are under increasing pressure from regulators, justices meet tomorrow to hear a case on preemption, Stryker experiencing several problems with its devices, FDA could move toward teleconference-based advisory council meetings, patent changes went into effect this weekend, and a paper takes a hard look at dietary supplements.

Abroad, a second compulsory license has been filed in India, Greece asked to void patent protections for some branded drugs, India's CDSCO receives a proposal to boost its regulatory capacity, EMA provides an update on labeling changes, A*Star announces development of a regulatory science tool, China's SFDA releases an annual report on adverse drug reactions, and Novartis' Jetrea gets EU approval.

Five in Focus:

  1. FDA Advisory Committees Could Become Teleconferences Due To Sequestration (The Pink Sheet Daily)
  2. Greece Urged to Overturn Patent Protections for Some Medicine, Import Low-Cost Generics in Wake of Fiscal Crisis (Financial Times)
  3. 4 Key Drug Approvals Expected In The Next 30 Days (Investor's Business Daily)
  4. Second Compulsory Licensing Application Filed in India (Spicy IP)
  5. Gujarat's FDCA Approaches National CDSCO With Proposal to Fund Upgrade of Regulatory Capacity (PharmaBiz)

In Memorium

  • Dr Reddy's Laboratories founder Anji Reddy passes away (Economic Times) (Bloomberg)
  • Obituary: George Miller Burditt, Food and Drug Lawyer, Recipient of Top RAPS Awards (FDA Law Blog)

US

Pharmaceuticals/Biotechnology
  • Biogen Idec awaits FDA decision on MS drug Tecfidera (Boston Globe)
  • FDA Chalks Up Pradaxa Safety Scare To "Stimulated Reporting" (The Pink Sheet Daily) ($)
  • Key Dems split with White House on allowing lawsuits over generic drugs (The Hill)
  • Compounding Pharmacies Feel More Heat (WSJ)
  • Medprep Consulting Inc. Announces Voluntary Nationwide Recall Of All Lots Of All Compounded Products Due To Potential Mold Contamination (FDA)
  • 4 Key Drug Approvals Expected In The Next 30 Days (Investor's Business Daily)
  • Generics Firm Sides With FTC (WSJ)
  • Statement of GPhA Regarding Resignation of Greg Geba (GPhA)
  • FDA approves new packet version of AbbVie testosterone gel (Drug Store News)
  • FDA Still Holding off on Issuing Further Guidance on Submitting Drug Sample Data Under Obamacare's Section 6004 (FDA)
  • Merck anesthesia-reversal agent faces new delay (Reuters) (Fierce Biotech)
  • Bayer sues Glenmark over its skin disorder generic (PM Live)
  • NYTimes Raises Questions About Whether New Alzheimers Drug Approval Paradigm Would Introduce Unsafe or Unbeneficial Medicines (NYTimes)
  • Will FDA Data Exclusivity Make Biologic Patents Passé? (Santa Clara Law Journal)
  • Can Diabetes Drugs Critics Say 'I Told You So?' (Pharmalot)
  • Teva Pays $2.3 Million For Pollution Violations (Pharmalot)
  • Battle over 'biosimilars' (LATimes) (Indy Star)
  • Colo. Attorney General Urges FDA to Crack Down on Rx Pill Abuse (KREX TV)
  • FDA investigates voluntary pharmacy product recalls (AP) (Hartford Courant)
  • Novartis Citizen Petition Asks FDA Not to Approve Any Generic Versions of Zoledtronic Acid Injectable IV (Reclast) Omitting Certain Information (FDA)
  • Top court to hear arguments on Tuesday over generic drugmaker liability (Reuters)
  • Generic Preemption Redux: Can Juries Deem A Drug Too Dangerous? (The Pink Sheet) ($)
  • GDUFA Facility Fees Should Be Waived Until First ANDA Approved, Petition Argues (The Pink Sheet) ($)
  • CDER's Office Of Pharmaceutical Quality Remains A Wild Card (The Pink Sheet)
  • BioCentury TV Examines the MODERN CURES Act (BioCenturyTV)
Medical Devices
  • FDA Warns of Injuries Involving Stryker Surgical Devices (WSJ)
  • Meetings: General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee (FDA)
  • FDA Adjusting Estimates for 510(k) Submission Burdens, Seeks Comment (FDA)
  • Illumina must fork over $96M in patent suit (Fierce Medical Devices)
  • Vivus hopes weight-loss app will fatten up Qsymia sales (Fierce Pharma)
  • Stryker's FDA Troubles Equals Opportunity for Firm Selling Novel Waste Management Device (MDDI)
  • Vascular Solutions Zerusa Ltd. Issues Recall of Guardian II and Guardian II NC Hemostasis Valves (FDA)
  • Doctors Group: Robot Surgery Shouldn't be First Choice for Uterus Removals (Bloomberg)
  • Meeting Materials of the Circulatory System Devices Panel (FDA)
  • Why Are Healthcare Costs Exploding? See Proton Cancer Therapy (Xconomy)
Assorted
  • FDA Advisory Committees Could Become Teleconferences Due To Sequestration (The Pink Sheet Daily)
  • Rep. Slaughter Reintroduces PAMTA, Criticizes FDA Strategy for Tackling Antibiotic Resistance (Food Safety News) (Slaughter)
  • FDA Doesn't Have Funding for a Full-Time Neonatologist, it Says (FDA)
  • Students Bring Energy and Regulatory Science Ideas to the Table (FDA)
  • Understanding changes to the America Invents Act that go into effect today (Med City News)
  • Sensitive test for malaria protein could help FDA better evaluate malaria vaccines and give public health workers a new tool for tracking outbreaks (FDA)
  • Is the Seller to Blame? Workout Supplement Challenged After Death of Soldier (NYTimes)
  • Learning the Hard Way About a Banned Ingredient (NYTimes)
  • Multibillion-dollar map of human brain might not be worth it (LATimes)
  • FDA develops simple and rapid poliovirus test to speed evaluation of vaccines and support global polio eradication campaign (FDA)
  • Elan/Wyth Insider-trading fine reaches record $600 million (The Hill) (The Guardian)
  • Prospective Grant of Start-Up Option Exclusive License: The Development of Liposomal Therapeutic Agents for the Treatment of Human Epithelial Cancers and Liposarcomas (NIH)
  • Biggest Loser Trainers Publicly Promote Diet And Exercise, Quietly Endorse Unproven Weight Loss Pills (Think Progress)
  • FDA Moving Forward With Cross-Species Test Immune System Reference Research (FDA)
  • Harvard, Sony collaborate for Organs-on-Chips (BioSpectrum)
Government and Budget
  • GAO details the high cost of continuing resolutions (FCW)
  • Pay freeze, furloughs might push employees to retire, but stats don't show it yet (Washington Post)
  • Federal worker pay freeze likely to be extended (CNN Money)
  • One Key Issue; Two Different Perspectives on FDA (Alliance for a Stronger FDA)
  • Budget bills head to House and Senate floors (The Hill)
  • CR could reduce furloughs, other cuts (Federal Times)
Meetings This Week
  • March 20, 2013: Circulatory System Devices Panel of the Medical Devices Advisory Committee Meeting Announcement (FDA) (Meeting Materials)
  • March 21, 2013: Meeting of the Psychopharmacologic Drugs Advisory Committee Meeting Announcement (FDA)
  • March 22, 2013: FDA Public Workshop: Innovations in Breast Cancer Drug Development - Neoadjuvant Breast Cancer Workshop (FDA)
  • March 19th, 2013: FDA Webinar: Buyer Beware: The Risks and Dangers of Purchasing Drugs Online (FDA)

International

  • Second Compulsory Licensing Application Filed in India (Spicy IP)
  • Greece Urged to Overturn Patent Protections for Some Medicine, Import Low-Cost Generics in Wake of Fiscal Crisis (Financial Times)
  • Dr Reddy's Laboratories founder Anji Reddy passes away (Economic Times) (Bloomberg)
  • SFDA releases 2012 Annual Report for National Adverse Drug Reaction Monitoring (SFDA)
  • Gujarat's FDCA Approaches National CDSCO With Proposal to Fund Upgrade of Regulatory Capacity (PharmaBiz)
  • European Medicines Agency updates product information template to label medicines subject to additional monitoring and encourage adverse-reaction reporting (EMA) (2)
  • European Medicines Agency and European Commission renew confidentiality arrangement with Canada (EMA)
  • A*Star artificial liver to speed up drug R&D (BioSpectrum)
  • US FDA norms on Non-clinical Safety Studies may be a relief to Indian CROs (PharmaBiz)
  • US Drug Shortages Turning Indian Drug Manufacturer Claris Into Takover Target (Bloomberg)
  • Informatics to drive clinical trials in UK (PM Live)
  • Draft guideline on the pharmacokinetic and clinical evaluation of modified release dosage forms (EMA/CPMP/EWP/280/96 Corr1) (EMA)
  • Europe Transparency Initiatives May Aid Progress Toward Adaptive Licensing Systems (The Pink Sheet) ($)
  • Consultation - Proposed Changes to the Therapeutic Products Directorate's List of Recognized Standards for Medical Devices (Health Canada)
  • EMA approves ThromboGenics' ocriplasmin (BioCentury)
  • IQWIG says Eylea has 'no additional benefit' (BioCentury)
  • Canada out with New Fees for DMFs, Foreign Sites, Sales Permission (Health Canada) (2) (3) (4)
  • Pfizer says ASA ruling won't affect wider supplement marketing (Nutra Ingredients)
  • China Revises Essential-Drugs List, Adding 520 More, 200 For Children (Pharm Asia News) ($)
  • India's Dept. of Pharmaceuticals Assessing Comments Regarding Establishment of a Uniform Marketing Practices Code (PharmaBiz)
  • Medical Council of India's dissolved governing body may be revived soon (PharmaBiz)
  • India's Union Health Min rules out irregularities in clinical trials involving children at Delhi hospitals (PharmaBiz)
  • India: Expert panels on new drugs, clinical trials & FDCs seek feedback from industry, NGOs (PharmaBiz)
  • Roche's Pegasys receives EU approval for the treatment of chronic hepatitis C in children five years of age and older (Roche) (Reuters)
  • Novartis says Alcon's eye drug Jetrea gets EU approval (Reuters) (Pharma Times)

Interesting

  • Device keeps liver "alive" outside body in medical first (Reuters)
  • Is Your Medicine Vegan? Probably Not (NPR)
  • With e-prescribing, doctors choose cheaper drugs (Fierce Health IT)
  • Famous 'HeLa' Human Cell Line Gets Its DNA Sequenced (Scientific American)

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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