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FDA News Flash January 9, 2012

FDA REGULATORY NEWS

• FDA’s new draft guidance document about the 510(k) premarket review program, issued December 27, 2011, is intended to clarify changes to the 510(k) program that occurred over the past couple of years as part of the 510(k) reform process.  However, many former FDA officials believe that this draft guidance document goes beyond the intended scope by introducing new concepts, such as “primary predicates” and “reference devices,” which may be more confusing than clarifying.  (The Gray Sheet)
• The Medical Device Manufacturers Association (MDMA) believes that FDA needs to narrow its focus as the agency continues 510(k) reform efforts.  Mark Leahey, MDMA’s President and CEO recommended that the agency focus on two or three areas that will have the most return on investment, such as the network of experts program, and new policies for weighing device benefits and risks.  (Health News Daily)
• In a December meeting between FDA Commissioner Margaret Hamburg and members of the Patient, Consumer and Public Health Coalition, the industry group expressed concern over a perceived agency eagerness to loosen the conflict of interest rules for advisory committees.  The consumer groups are worried that inclusion of committee members with conflicts could erode FDA’s decision making process.  (The Pink Sheet)

FDA COMPLIANCE NEWS

• Responding to FDA’s August 2011 draft guidance document which seeks to bolster the use of centralized clinical trial monitoring as opposed to onsite monitoring, the Association of Clinical Research Organizations industry group expressed concern that a centralized monitoring system may be overly burdensome.  Specifically, industry members feel that a centralized monitoring system may not apply to all types of studies, such as clinical trials, and that the final guidance document should specify what technologies and clinical trial phases and indications are acceptable for centralized monitoring.  (The Pink Sheet)

CLIENT NEWS

• Abbott’s Freestyle glucose test strip receives 510(k) clearance for use with Insulet’s OmniPod insulin pump (MassDevice)
• Allergan to invest $350M in manufacturing plant in Ireland (Reuters)
• Invacare appoints Doug Uelmen as Senior Vice President, Quality Assurance and Regulatory Affairs (The Gray Sheet)
• Lantheus Medical Imaging names Jeffrey Young as CFO (The Gray Sheet)

 

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MEETINGS

This week

• Public Workshop.  January 10-11, 2012.  The Development and Evaluation of Human Cytomegalovirus Vaccines.  Identify and discuss key issues related to the development and evaluation of human cytomegalovirus (HCMV) vaccines.  [FR Notice]
• Gastroenterology and Urology Devices Panel of the Medical Devices Advisory Committee.  January 11, 2012.  Discuss, make recommendations, and vote on information related to the premarket approval application, sponsored by Torax Medical, Inc., for the LINX Reflux Management System, a sterile, single use, surgically placed device used to treat the symptoms associated with gastroesophageal reflux disease.  [FR Notice]

Next 30 days

• Tobacco Products Scientific Advisory Committee Meeting.  January 18-19, 2012.  Discuss issues related to the nature and impact of the use of dissolvable tobacco products on the public health, including such use among children, and discuss topics such as the composition and characteristics of dissolvable tobacco products, product use, potential health effects, and marketing.  [FR Notice]
• Advisory Committee for Reproductive Health Drugs.  January 20, 2012.  Discuss the benefits and risks of new drug application 22-139 progesterone gel 8%, Columbia Laboratories, Inc., for the proposed indication of “reduction of risk of preterm birth in women with short uterine cervical length regardless of other risk factors in the mid-trimester of pregnancy.”  Columbia Laboratories, Inc., (NASDAQ:CBRX).  [FR Notice]
• Pediatric Advisory Committee.  January 30, 2011.  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]
• 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]

Next 90 days

• 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]
• 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]
• 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]
• 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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