FDA Policy/General
Federal Register Notice: FDA has published a draft guidance on “FDA Categorization of Investigational Device Exemption (IDE) Devices to Assist the Centers for Medicare and Medicaid Services (CMS) with Coverage Decisions.” The document modifies FDA’s current policy on categorization of IDE devices, which assists CMS in determining whether an
Devices
FDA has approved Roche’s cobas EGFR Mutation Test v2, a companion diagnostic for the cancer drug Tarceva (erlotinib) that is the first blood-based genetic test detect epidermal growth factor receptor (EGFR) gene mutations in non-small cell lung cancer patients, according to an agency release. “With the cobas
Biologics
FDA has asked the Office of Management and Budget to approve an information request outlined in a 2015 draft guidance on Nonproprietary Naming of Biological Products that would have biologic and biosimilar product sponsors submitting proposed suffixes to be incorporated in the nonproprietary name on such products (see story). According
Drugs
CDER Office of Compliance manufacturing quality guidance and policy staff director Paula Katz says that three key elements in a drug company’s response to a data integrity Warning Letter are a comprehensive evaluation, risk assessment, and remediation and a management strategy. Speaking at a Parenteral Drug Association Manufacturing Science
Drugs
FDA has issued Teva Pharmaceutical Industries a Complete Response Letter on its NDA for SD-809 (deutetrabenazine) tablets for treating chorea-associated Huntington disease. The agency has asked Teva to examine blood levels of certain metabolites, according to the company. “These metabolites are not novel, and are the same seen
Drugs
The New Jersey federal court has granted an FDA motion seeking dismissal of a case brought against it by Health Science Funding, which developed and markets as a medical food Prastera, a pharmaceutically pure dehydroepiandrosterone product. The company typically sells Prastera as a dietary supplement for women with lupus. In
Drugs
FDA has approved Advanced Accelerator Applications’ Netspot, the first kit for preparing gallium Ga 68 dotatate injection, a radioactive diagnostic agent for locating somatostatin receptor positive neuroendocrine tumors (NETs) in adult and pediatric patients. NETs are rare benign or malignant tumors that develop in the hormone-producing cells of the
Drugs
FDA has accepted for review a Radius Health NDA for abaloparatide-SC, indicated for treating postmenopausal women with osteoporosis. The submission is supported by data from an 18-month Phase 3 trial called ACTIVE, which evaluated 2,463 postmenopausal women with osteoporosis. It also includes data from the first six
Devices
Three CDRH officials say the Expedited Access Program (EAP), which is completing its first year, allows FDA and medical device sponsors to focus on the early stages of product development, which can be helpful for new products that address unmet and critical life-threatening patient needs. “In fact,” they write
Drugs
Republican leaders of the House Energy and Commerce Committee say they understand that FDA’s failure to publicly clarify its thinking on communication of truthful and non-misleading information on off-label uses of drugs and medical devices may be due to a disagreement between FDA and HHS leadership. In
Drugs
The U.S. Chamber Institute for Legal Reform says that although it is too soon to measure the full impact of the 9/2015 Justice Department policy memorandum directing attorneys to focus enforcement efforts on holding individuals accountable for corporate malfeasance (memo from deputy attorney general Sally Yates), “it is
Devices
A petition submitted to FDA by Philadelphia heart surgeon and power morcellation activist Hooman Noorchashm asks that the agency revoke CDRH clearance of the Advanced Surgical Concepts Pneumoliner containment system use with power morcellators. The petition says that the clearance should be revoked “on the basis of inadequate oncological safety
Drugs
FDA has determined that Amarin Pharmaceuticals’ Vascepa (icosapent ethyl) capsules are now eligible for five-year, new chemical entity marketing exclusivity under the Hatch-Waxman Amendments. The exclusivity period will run until 7/2017, and the statutory 30-month stay triggered by patent litigation following a generic application submission would
Drugs
A 5/21-29/15 FDA inspection at Corden Pharma Latina, Sermoneta, Italy, found significant violations of current good manufacturing practice (CGMP) regulations for finished pharmaceuticals and significant deviations from CGMP for active pharmaceutical ingredients. A 5/20 Warning Letter says that specific violations and deviations included: * failing to have
Devices
FDA has issued a draft guidance, FDA Categorization of Investigational Device Exemption (IDE) Devices to Assist the Centers for Medicare and Medicaid Services (CMS) with Coverage Decisions, modifying the agency’s current policy on the subject. The document is intended to implement a 12/2/15 memorandum of understanding between
Drugs
FDA says that Megafine Pharma, Mumbai, India, was placed on a 10/14/15 import alert due to findings from a 5/11-15/15 inspection showing significant deviations from current good manufacturing practice for active pharmaceutical ingredients (API). A 5/19 Warning Letter says that specific violations included: * failing
Devices
The FDA Circulatory Devices Panel of the Medical Devices Advisory Committee will discuss at its 6/2-3 meeting concerns about the adequacy of cleaning and disinfection of heater-cooler devices (HCD) and how to best remediate the mode of nontuberculous mycobacteria (NTM) aerosolized transmission from the heater-cooler device
Drugs
FDA has granted Intercept Pharmaceuticals accelerated approval for Ocaliva (obeticholic acid) for treating primary biliary cholangitis in combination with ursodeoxycholic acid (UDCA) in adults with an inadequate response to UDCA, or as a single therapy in adults unable to tolerate UDCA. The condition causes the small bile ducts in the
FDA Policy/General
Bedford Pharmacy Bedford, NH (5/18). Inspected 8/10-28/2015. Serious deficiencies cited for firm’s practices for producing compounded sterile drug products. Investigators noted that firm’s aseptic processing occurs in an unclassified room and is turned off when not in use. The firm also failed to use
FDA Policy/General
Federal Register Notice: FDA announces its intention to accept and consider a single source application for a $2 million grant toward a cooperative agreement with the World Health Organization for regulatory systems strengthening, development of norms and standards, and innovative research to advance global access to safe and effective biological
FDA Policy/General
Federal Register Notice: FDA announces its intention to accept and consider a single source application for a $2 million grant toward a cooperative agreement with the World Health Organization for regulatory systems strengthening, development of norms and standards, and innovative research to advance global access to safe and effective biological
FDA Policy/General
Federal Register Notice: Public workshop on “Facilitating Antibacterial Drug Development for Patients With Unmet Need and Developing Antibacterial Drugs That Target a Single Species Media.” The workshop will discussing scientific challenges pertaining to such development programs, including enrollment challenges, clinical trial designs, and trial population. It will be held 7/