FDA Policy/General
Draft Guide on Drug Indications Labeling Federal Register notice: FDA makes available a draft guidance entitled “Indications and Usage Section of Labeling for Human Prescription Drug and Biological Products — Content and Format.” 07/09/2018 Comments Sought on Biosimilar Info Collection Federal Register notice: FDA seeks comments on a information
FDA Policy/General
Federal Register notice: FDA has made available a final guidance entitled “Assessing User Fees Under the Biosimilar User Fee Amendments of 2017.” The document addresses FDA’s implementation of the biosimilar user fee program and certain changes in policies and procedures. To view the notice, click here.
Drugs
FDA has approved a Pulmonx PMA for the Zephyr Endobronchial Valve, intended to treat breathing difficulty associated with severe emphysema. “Using a flexible bronchoscope, a doctor places Zephyr Valves, similar in size to pencil erasers, into the diseased areas of the lung airways during a procedure in a hospital setting,
Devices
FDA has cleared an Arthrosurface 510(k) to market the Patellofemoral WaveKahuna Arthroplasty System. The implants are intended to restore the articular surface geometry of the patella and femoral trochlea while maintaining a patient’s native anatomy, according to the company. Their extended lateral aspect and trochlear geometry are designed
Drugs
Federal Register notice: FDA has announced a 2018 CDER and CBER staff experiential learning site visit program specific to its Quality Metrics Program. The proposed program is in response to input from a variety of stakeholders over the past couple of years. The purpose of the site visit program is
Drugs
FDA says it is stepping up pressure on drug compounding facilities, particularly those preparing topical pain creams comprised of multiple ingredients. “Oftentimes, at least one of the ingredients is an active ingredient in an FDA-approved topical pain cream, such as lidocaine,” an agency release says. Other ingredients is these
Drugs
FDA is advising health care professionals not to use BioDiagnostics International’s Monsel’s Solution (ferric subsulfate 20%) because the drug product was made under poor conditions. The product is used to stop bleeding after medical procedures, such as a colposcopy and a biopsy. The solution is sold in a
FDA Policy/General
In observance of the Fourth of July (Independence Day) holiday in the U.S., the news operations of FDA Webview are closed until Monday, July 9. The next overnight email news bulletin from this site will be issued that evening.
FDA Policy/General
Federal Register notice: FDA has made available a draft guidance entitled “Oncology Therapeutic Radiopharmaceuticals: Nonclinical Studies and Labeling Recommendations.” The document discusses how to design appropriate nonclinical studies before beginning first-in-human trials and through product approval. In addition, it provides recommendations for product labeling, such as duration of
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