Drugs
FDA has issued a draft guidance, Oncology Therapeutic Radiopharmaceuticals: Nonclinical Studies and Labeling Recommendations, to help sponsors design an appropriate nonclinical program for development of radiopharmaceuticals to treat cancer and to give recommendations for certain aspects of product labeling. The document defines a therapeutic radiopharmaceutical as a product that contains
Drugs
FDA has issued a guidance, Assessing User Fees Under the Biosimilar User Fee Amendments of 2017, to give stakeholders information on the agency’s implementation of the Biosimilar User Fee Amendments of 2017 (BsUFA 2). The document describes the types of user fees authorized by BsUFA 2, the process for
Drugs
FDA says it has started two new programs to gather feedback on using quality metrics to modernize pharmaceutical quality systems and advance innovation. An agency Small Business Buzz online post says the Quality Metrics Feedback Program and the Quality Metrics Site Visit Program build on stakeholder comments requesting continued dialog
Drugs
FDA has granted Rafael Pharmaceuticals an orphan drug designation for CPI-613, an altered energy metabolism-directed drug candidate for treating Burkitt Lymphoma. The highly aggressive hematologic B-cell malignancy is characterized by the overexpression of c-Myc, the company says. CPI-613 is a novel lipoic acid analog with
FDA Policy/General
Federal Register notice: FDA has announced an 8/22 public workshop entitled “Development of Non-Traditional Therapies for Bacterial Infections.” Attendees will discuss the general development considerations of non-traditional therapies, including pre-clinical development, early clinical studies, and Phase3 clinical trial designs to evaluate safety and efficacy. To view
FDA Policy/General
FDA has published a guidance, Antimicrobial Animal Drug Sales and Distribution Reporting Small Entity Compliance Guide, to help small businesses comply with the agency’s antimicrobial animal drug sales and distribution final rule. The document uses a question-and-answer format to help antimicrobial animal drug sponsors to annually report
FDA Policy/General
Federal Register notice: FDA is seeking comments on an information collection extension for “Biosimilars User Fee Program” (OMB Control Number 0910-0718). To view the notice, click here.
FDA Policy/General
Federal Register notice: FDA has announced a 9/12 public hearing to solicit comments on its Predictive Toxicology Roadmap. The agency is seeking comments on how to foster the development and evaluation of emerging toxicological methods and new technologies and incorporate these methods and technologies into regulatory reviews. To view
Drugs
FDA has published a 32-page FDA-483 with 13 observations issued following a 3/19-4/12 inspection at the Mylan Pharmaceuticals finished drug manufacturing facility in Morgantown, WV. The specific inspection observations were: * failing to fully follow the responsibilities and procedures applicable to the quality control unit; * failing
Devices
FDA has cleared a Renovis Surgical Technologies 510(k) for the Tesera SA Hyperlordotic ALIF Interbody Spinal Fusion System. The porous titanium stand-alone anterior lumbar interbody fusion system features a four-screw design and a locking cover plate to prevent screw backout, according to the company. All implants utilize
Devices
FDA has cleared an Embolx 510(k) for its next generation Sniper Balloon Occlusion Microcatheter, intended for use for pressure-directed arterial embolization therapy. The device is available in three lengths — 110 cm, 130 cm and 150 cm — to allow interventional radiologist physicians to access either femoral or radial arterial
FDA Policy/General
CDER’s Office of Prescription Drug Promotion (OPDP) says a direct-to-consumer video of an interview featuring paid and trained Pfizer spokespersons about its Estring (estradiol vaginal ring) makes false or misleading claims and/or representations about the product’s risks and efficacy. A 6/19 notice of violation
FDA Policy/General
A new FDA report outlines the agency’s current workforce needs as mandated by the 21st Century Cures Act. New authority in the Act “provides tools to efficiently recruit and retain scientific, technical, and professional staff needed to continue advancing innovation and fulfilling FDA’ s mission,” the report says. The
Drugs
Generic drug stakeholders have recommended regulatory science research topics for FDA to pursue in Fiscal Year 2019. The Association for Accessible Medicines suggests: orally inhaled products, in-vitro methods, biowaivers, global reference product, CQAs, human factors considerations for sameness, identifying in-vitro alternatives to clinical endpoint studies, assessment of suitability
Drugs
Members of the FDA Anesthetic and Analgesic Drug Products Advisory Committee and the agency’s Drug Safety Advisory Committee have voted 14-3 to recommend that FDA not approve Pain Therapeutics’ Remoxy ER (oxycodone extended-release capsules) for management of pain severe enough to require daily, around-the-clock, long-
Drugs
FDA has released the FDA-483s issued following an agency 3/26-3/30 inspection at one Galaxy Surfactants manufacturing facility in Tarapur, India, and a 3/19-3/23 inspection at a second manufacturing facility in the same city. Observations from the first report were: * responsibilities and procedures applicable
Devices
FDA has permitted the de novo marketing of Fresca Medical’s Curve Positive Airway Pressure delivery system for treating obstructive sleep apnea. The device includes a dedicated flow generator, a lightweight and ergonomic air delivery hose, and a nasal pillow patient interface. According to Fresca Medical, it features the company’
Devices
FDA has cleared a Beckman Coulter Diagnostics 510(k) for its new high-sensitivity troponin assay, Access hsTnI, for use on the Access 2, DxI and all Access immunoassay systems. The assay is intended to detect troponin I, a protein that is present in circulation during myocardial infarction. The test
Drugs
FDA has released the FDA-483 issued to Exela Pharma Sciences, a Lenoir, NC, outsourcing facility, following a 9/19-9/28/17 inspection. Specific observations on the form were: * failing to handle and store components and drug product containers at all times in a manner to prevent contamination; * aseptic
FDA Policy/General
Public Citizen says FDA should immediately require the removal from the market of all medications containing the widely prescribed xanthine oxidase inhibitor febuxostat (Takeda’s Uloric) because (1) febuxostat increases the risk of death compared with alternative therapies and (2) there exist other effective medications that had been approved by
Drugs
FDA has granted Revive Therapeutics an orphan drug designation for cannabidiol (CBD) for treating autoimmune hepatitis (AIH), a rare disease that causes inflammation to the liver. The current standard of care is the use of steroids alone or steroids combined with azathioprine, which can cause severe treatment-related side effects
FDA Policy/General
Federal Register notice: FDA has submitted for OMB approval a proposed information extension for “State Enforcement Notifications” (OMB Control Number 0910-0275). FDA’s regulations authorize a state to enforce certain sections of the FD&C Act within its own jurisdiction. However, before doing so, a state must provide