Devices
FDA has posted a guidance on “Logical Observation Identifiers Names and Codes for In Vitro Diagnostic (IVD) Tests.” FDA notes that with the use of electronic health records (EHR), there has been a greater demand to standardize the way that IVDs are coded. The document discusses how laboratories commonly associate
Drugs
Public Citizen says the Senate Judiciary Committee “threw a punch for affordable prescriptions” 6/14 by voting to advance the CREATES Act that would prevent branded drug manufacturers from abusing regulatory rules to deny generic and biosimilar manufacturers access to product samples. “Corporations have long used this practice to delay
Devices
Members of the FDA Circulatory System Devices Advisory Committee voted 11-4 on 6/12 to recommend that the agency give premarket approval to Cordis’ Incraft stent-graft device for abdominal aortic aneurysms. FierceBiotech reports that the device is deployed through the artery and opened to seal and relieve pressure
Drugs
FDA has published a draft guidance, Human Immunodeficiency Virus-1 Infection: Developing Systemic Drug Products for Pre-Exposure Prophylaxis, to give sponsors clinical and non-clinical recommendations specific to developing systemic drug products, with a focus on long-acting systemic drug products regulated within CDER for preventing sexually acquired HIV-
Drugs
FDA says the manufacturers and labelers of 11 drug products that contain isometheptene agreed to comply with a 10/12/17 agency order to stop distributing their isometheptene mucate-containing drug products as of 1/1/18. An agency notice says the affected products contain either isometheptene mucate, discloralphenazone, and
Devices
FDA has issued a draft guidance, Intravascular Catheters, Wires, and Delivery Systems with Lubricious Coatings—Labeling Considerations, with recommendations for information to be included in the device labeling submitted in PMAs or 510(k)s for Class 3 and 2 devices containing lubricious coatings used in the vasculature to enhance
Devices
FDA has issued a draft guidance, Coronary, Peripheral, and Neurovascular Guidewires—Performance Testing and Recommended Labeling, to assist industry in designing and executing appropriate performance testing to support a premarket notification. It also provides recommendations for content and labeling to include in 510(k) submissions. When final, the document will
FDA Policy/General
Federal Register notice: FDA has classified brain trauma assessment tests into Class 2 (special controls). The devices are identified as those comprising reagents used to detect and measure brain injury biomarkers in human specimens. The measurements aid in the evaluation of patients with suspected mild traumatic brain injury in conjunction
FDA Policy/General
Federal Register notice: FDA has classified the endoscopic electrosurgical clip cutting system into Class 2 (special controls). The agency has identified it as a prescription device that applies electrical energy to fragment metallic clips, which are devices placed in the digestive tract to close gastrointestinal perforations, hemorrhages, or perform resection.
FDA Policy/General
Federal Register notice: FDA has made available a draft guidance entitled “Patient-Focused Drug Development: Collecting Comprehensive and Representative Input.” The document is the first of a series of four methodological guidances that FDA committed to develop to address how to collect and submit information from patients and caregivers for
FDA Policy/General
Federal Register notice: FDA has made available a draft guidance entitled “Humanitarian Device Exemption (HDE) Program.” The document explains the criteria FDA considers to determine if “probable benefit” has been demonstrated as part of its decision-making process regarding marketing authorization for such devices. It also incorporates recent amendments that
Biologics
CBER says that as of 10/1, it will increase the use of secure e-mail for regulatory communications in an effort to streamline and facilitate communication with sponsors and protect proprietary and company confidential information. After 10/1, the notice says, outgoing e-mail communications containing regulatory information will
Devices
FDA has cleared a LivaNova 510(k) for its MEMO 4D semi-rigid mitral annuloplasty ring. The next-generation addition to the MEMO line offers a broader range of ring sizes from 24 to 42mm allowing an additional patient population with mitral regurgitation (MR) to be treated, according to the
Devices
FDA has cleared an Optovue 510(k) for its Avanti Widefield Optical Coherence Tomography system for non-contact, quantitative measurements of the epithelial and stromal layers of the cornea (epithelial thickness mapping or ETM). The expanded clearance adds a nine-millimeter ETM scan to the previously available six-millimeter map,
FDA Policy/General
Federal Register notice: FDA has issued a proposed list of alternative or streamlined mechanisms for complying with GMP requirements for combination products. The listing is mandated by the 21st Century Cures Act. Electronic or written comments on the notice are encouraged by 9/11. To view the notice, click here.
FDA Policy/General
Federal Register notice: FDA has made available a guidance entitled “Drug and Device Manufacturer Communications With Payors, Formulary Committees, and Similar Entities — Questions and Answers.” The document provides answers to common questions on communicating health care economic information to this specific audience. It also provides answers to common questions about
FDA Policy/General
Federal Register notice: FDA has made available a guidance for industry entitled “Medical Product Communications That Are Consistent With the FDA-Required Labeling — Questions and Answers.” The document provides information about how FDA evaluates medical product communications that present information that is not contained in the FDA-required labeling for
FDA Policy/General
Federal Register notice: FDA has made available a draft guidance entitled “Limited Population Pathway for Antibacterial and Antifungal Drugs.” The document provides information on implementing the limited population pathway provision of the 21st Century Cures Act for such products. To view the notice, click here.
Drugs
FDA has issued scPharmaceuticals a complete response letter on its 505(b)(2) NDA for Furoscix (subcutaneous furosemide) for treating edema or fluid overload in patients with heart failure. The letter indicated the need for additional human factors studies, device modifications, and potentially a clinical validation study, according to the
Drugs
FDA has approved Genentech’s Avastin (bevacizumab) for use in combination with chemotherapy (carboplatin and paclitaxel), followed by Avastin as a single agent, for treating women with advanced (stage III or IV) ovarian cancer following initial surgical resection. Approval is based on data from the pivotal Phase 3 GOG-0218
Devices
FDA has approved a Wright Medical Group PMA for Augment Bone Graft for use in hindfoot and ankle fusion. The injectable product combines recombinant human platelet-derived growth factor and a blend of Type 1 collagen and beta tri-calcium phosphate, which is designed as an alternative to autograft. The
Drugs
FDA has accepted for review a Sunovion NDA for apomorphine sublingual film (APL-130277) to treat motor fluctuations (OFF episodes) experienced by people living with Parkinson’s disease. The agency has set a user fee review action target date of 1/29/2019. The company says apomorphine sublingual film is