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FDA News Flash                                                             January 30, 2012

FDA REGULATORY NEWS

• On Friday, FDA approved Inlyta (axitinib) for treatment in patients with renal cell carcinoma who have not responded to other drugs for this cancer type.  Since 2005, seven drugs have been approved for the treatment of metastatic or advanced kidney cell cancer, which, according to Dr. Richard Pazdur, Director of the Office of Hematology and Oncology Products in FDA’s Center for Drug Evaluation and Research (CDER), has significantly altered the treatment paradigm for metastatic kidney cancer.   (FDA.gov)
• The industry group, mHealth Regulatory Coalition is asking FDA to release updates of its July 2011 draft guidance document of mobile medical applications regulation before it issues a final document.  The mHealth Regulatory Coalition would like another opportunity for public feedback on needed changes to a document that received “more than 500 pages” of feedback when released as a draft guidance document in July.  (The Gray Sheet)
• In drafting regulation to better handle how transfers of ownership of 510(k) clearances are updated in FDA’s systems, the agency is facing problems of how to make the process entirely electronic and least burdensome for companies, two goals set forth by Marjorie Shulman, FDA’s Center for Devices and Radiological Health’s (CDRH) acting director of the 510(k) program, in a January 2012 Regulatory Affairs Professionals Society (RAPS) webinar.  Currently, the agency is thinking of linking the 510(k) database to the registration and listing database in order to best track ownership of 510(k)s.  (The Gray Sheet)

 

FDA COMPLIANCE NEWS

• FDA’s Marry Willy, Deputy Director of the Center for Drug Evaluation and Research’s (CDER) Division of Risk Management in the Office of Medication Error Prevention and Risk Management, acknowledged the agency’s lack of methods for assessing burden and access, and stated that the agency is continuing to identify different metrics to be used to measure burden.  An analysis of 144 Risk Evaluation and Mitigation Strategies (REMS) in 2011 showed that the majority of assessments failed to give clear results about risk minimization.  (The Pink Sheet)

 

CLIENT NEWS

• Cardinal Health and Cook Medical announce exclusive agreement for customizable vascular access kitting solution (BusinessWire)
• Illumina sets response timeline to Roche offer (Reuters)
• Medtronic announces FDA approval of DF4 High-Voltage Connector System for implantable cardioverter defibrillator and cardiac resynchronization therapy devices (Medtronic Press Release)
• Roche partners with Technoclone to co-develop coagulation assays (Medical Devices Business Review)

 

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MEETINGS

 

• NEW:  Pulmonary-Allergy Drugs Advisory Committee.  February 23, 2012.  Discuss new drug application (NDA) 202450, for aclidinium bromide, sponsored by Forest Laboratories, for the proposed indication of long-term maintenance treatment of bronchospasm associated with chronic obstructive pulmonary disease, including chronic bronchitis and emphysema.  Forest Laboratories, Inc., (NYSE:FRX) [FR Notice]
• NEW:  Blood Products Advisory Committee.  February 29, 2012.  Discuss the evaluation of possible new plasma products manufactured following storage at room temperature for up to 24 hours, namely, plasma for transfusion prepared from whole blood held at room temperature for up to 24 hours prior to separation and freezing, or from apheresis plasma held at room temperature for up to 24 hours before freezing.  [FR Notice]
• NEW:  Public Conference.  March 19-20, 2012.  The FDA/Pharmaceutical Users Software Exchange (PhUSE) Annual Computational Science Symposium.  Align and share experiences to advance computational science, update participants on current FDA initiatives and address specific challenges in accessing and reviewing data to support product development.  [FR Notice]

 

This week

• Pediatric Advisory Committee.  January 30, 2012.  Discuss pediatric-focused safety reviews, as mandated by the Best Pharmaceuticals for Children Act and the Pediatric Research Equity Act for Prevnar 13 (Pneumococcal 13-valent Conjugate Vaccine (Diphtheria CRM197 Protein), Cervarix (Human Papillomavirus Bivalent (Types 16 and 18) vaccine, recombinant, Focalin XR (dexmethylphenidate), Daytrana (methylphenidate), Seroquel (quetiapine), Pancreaze (pancrelipase), Zenpep (pancrelipase), Creon (pancrelipase), Xerese cream 5%/1% (acyclovir and hydrocortisone), Xolair (omalizumab), Benicar (olmesartan medoxomil), Atacand (candesartan cilexetil), Mirena (levonorgestrel— releasing intrauterine system), Plan B One Step (levonorgestrel), and Flomax (tamsulosin).  [FR Notice]

 

Next week

• Oncologic Drugs Advisory Committee.  February 8, 2012.  Discuss supplemental biologics license application 125320/28 for XGEVA (denosumab) injection, application submitted by Amgen, Inc.  The proposed indication for this product is for the treatment of men with castrate-resistant prostate cancer at high risk of developing bone metastases, or spread of cancer to the bones.  Amgen, Inc., (NASDAQ:AMGN).  [FR Notice]
• Oncologic Drugs Advisory Committee.  February 9, 2012.  Discuss supplemental new drug application (NDA) 21790/010 for DACOGEN (decitabine) for injection, application submitted by Eisai, Inc.  The proposed indication for this product is for the treatment of acute myelogenous leukemia (AML) in adults 65 years of age or older who are not considered candidates for induction chemotherapy.  Discuss NDA 022481, with the proposed trade name PIXUVRI (pixantrone dimaleate) injection, application submitted by Cell Therapeutics, Inc.  The proposed indication for this product is as a single agent treatment for patients with relapsed or refractory, aggressive Non-Hodgkin’s Lymphoma who received two or more prior lines of therapy.  Cell Therapeutics, Inc., (NASDAQ:CTIC).  [FR Notice]
• Anesthetic and Analgesic Drug Products Advisory Committee.  February 9, 2012.  Discuss the available efficacy and safety data for supplemental new drug application (sNDA) 22395/S–013, QUTENZA (capsaicin 8%) Patch, by NeurogesX, Inc., for the proposed indication of management of neuropathic pain (nerve pain) related to HIV-associated peripheral neuropathy.  NeurogesX, Inc., (NASDAQ:NGSX).  [FR Notice]
• Neurological Devices Panel of the Medical Devices Advisory Committee.  February 10, 2012.  Discuss and make recommendations regarding the possible reclassification of cranial electrotherapy stimulator (CES) devices.  [FR Notice]
• Cellular, Tissue, and Gene Therapies Advisory Committee.  February 10, 2012.  Hear updates of the research programs in the Cellular and Tissue Branch, Office of Cellular, Tissue and Gene Therapies, Center for Biologics Evaluation and Research, FDA.  [FR Notice]

 

Next 30 days

• Public Workshop.  February 15, 2012.  Ethical and Regulatory Challenges in the Development of Pediatric Medical Countermeasures.  Plenaries and breakout sessions on the ethical and regulatory challenges in the development of medical countermeasures for the pediatric population.  [FR Notice]
• Endocrinologic and Metabolic Drugs Advisory Committee.  February 22, 2012.  Discuss the safety and efficacy of new drug application (NDA) 22-580, proposed trade name QNEXA (phentermine/topiramate) Controlled-Release Capsules, manufactured by VIVUS, Inc., as an adjunct to diet and exercise for weight management in patients with a body mass index (BMI) equal to or greater than 30 kilograms (kg) per square meter or a BMI equal to or greater than 27 kg per square meter if accompanied by weight-related comorbidities.  VIVUS, Inc., (NASDAQ:VVUS).  [FR Notice]
• Cardiovascular and Renal Drugs Advisory Committee.  February 23, 2012.  Discuss the new drug application (NDA) 203202, proposed trade name NORTHERA (droxidopa capsules), submitted by Chelsea Therapeutics, Inc., for the treatment of symptomatic neurogenic orthostatic hypotension in patients with primary autonomic failure (Parkinson’s Disease, Multiple System Atrophy, and Pure Autonomic Failure), Dopamine Beta-Hydroxylase Deficiency, and Non-Diabetic Autonomic Neuropathy.  Chelsea Therapeutics, Inc., (NASDAQ:CHTP).  [FR Notice]
• Dermatologic and Ophthalmic Drugs Advisory Committee.  February 27, 2012.  Comment on the following topics related to the use of ophthalmic drug products:  Appropriate types of clinical evidence for developing anti-inflammatory drugs for the treatment of postoperative drugs and reduction of ocular pain in patients who have undergone ocular surgery; and the appropriateness of marketing a single bottle of ophthalmic product for use in both eyes for postsurgical indications as it relates to the potential risk for infection.  [FR Notice]
• Vaccines and Related Biological Products Advisory Committee.  February 28-29, 2012.  On February 28, hear an overview of the research program in the Laboratory of Mycobacterial Diseases and Cellular Immunology, Division of Bacterial, Parasitic and Allergenic Products, Office of Vaccines Research and Review, Center for Biologics Evaluation and Research, FDA, and discuss and make recommendations on the selection of strains to be included in the influenza virus vaccine for the 2012 and 2013 influenza season.  On February 29, discuss licensure pathways for pandemic influenza vaccines.  [FR Notice]

 

Next 90 days

• FDA Rare Disease Patient Advocacy Day.  March 1, 2012.  Meeting to enhance the awareness of the rare disease community as to FDA’s roles and responsibilities in the development of products (drugs, biological products, and devices) intended for the diagnosis, prevention, and/or treatment of rare diseases or conditions.  [FR Notice] 
• Public Workshop.  March 7-8, 2012.  FDA Clinical Trial Requirements, Regulations, Compliance, and Good Clinical Practice.  Co-sponsored by the FDA Los Angeles District Office and the Society of Clinical Research Associates (SoCRA).  Aid the clinical research professional’s understanding of the mission, responsibilities, and authority of the FDA and to facilitate interaction with FDA representatives; focus on the relationships among FDA and clinical trial staff, investigators, and institutional review boards (IRB).  [FR Notice]
• Arthritis Advisory Committee Meeting.  March 12, 2012.  Discuss the anti-nerve growth factor (Anti-NGF) drug class that is currently under development and the safety issues possibly related to these drugs.  [FR Notice]
• Pharmaceutical Science and Clinical Pharmacology Advisory Committee Meeting.  March 14, 2012.  Discuss the clinical pharmacology aspects of  pediatric clinical trial design and dosing to optimize pediatric drug development.  [FR Notice]
• Public Workshop.  May 3, 2012.  Clinical Development Programs for Sedation Products.  Solicit information on a variety of issues related to the clinical development and use of sedation products in adult and pediatric age groups as FDA develops guidance on clinical development programs for sedation products.  [FR Notice] 
• Public Workshop.  April 12, 2012.  Role of Naloxone in Opioid Overdose Fatality Prevention.  [FR Notice]
• POSTPONED:  Immunology Devices Panel.  TBD.  Discuss, make recommendations, and vote on a premarket approval application for the Progensa PCA3 assay, which is indicated to aid in the decision for repeat biopsy in men 50 years of age or older who have had one or more previous negative prostate biopsies and for whom a repeat biopsy would be recommended based on current standard of care, before consideration of PCA3 assay results.  Gen-Probe, Inc., (NASDAQ:GPRO).  [FR Notice]

  

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