FDA Policy/General
Federal Register notice: FDA has determined that EKR Therapeutics’ hypertension drug Cardene SR (nicardipine HCl) extended-release capsule (30 mg, 45 mg, and 60 mg) was not withdrawn from sale for reasons of safety or effectiveness. The determination will allow FDA to approve ANDAs that reference the drug product if
Drugs
FDA has cleared three antimicrobial susceptibility tests (ASTs) for determining the appropriate usage of Melinta Therapeutics’ Baxdela (delafloxacin), a fluoroquinolone indicated in adults for treating bacterial skin and skin structure infections caused by susceptible bacteria. The three ASTs that have been cleared are: Hardy Diagnostics’ Delafloxacin Antimicrobial Susceptibility Disk (HardyDisk)
Drugs
FDA has approved a Janssen Pharmaceuticals supplemental NDA for a 10 mg once-daily dose of Xarelto (rivaroxaban) for reducing the continued risk for recurrent venous thromboembolism (VTE) after completing at least six months of initial anticoagulation therapy. The approval is based on data from the EINSTEIN CHOICE clinical study
Drugs
FDA has published an International Council for Harmonization guidance entitled “E9 (R1) Statistical Principles for Clinical Trials: Addendum: Estimands and Sensitivity Analysis in Clinical Trials.” The addendum presents a structured framework to link trial objectives to a suitable trial design and tools for estimation and hypothesis testing. It introduces the
FDA Policy/General
Federal Register notice: FDA has published the following six medical device classification notices: * Clinical chemistry and clinical toxicology devices — De novo classification of Astute Medical’s Nephrocheck Acute Kidney Injury Test System. * Immunology and microbiology devices — De novo classification of Quidel Corp.’s Lyra Direct Streptococcus SPP Nucleic Acid-Based
FDA Policy/General
Federal Register notice: FDA has reopened the comment period to allow additional time for comments related to a workshop on “Voluntary Medical Device Manufacturing and Product Quality Program.” Comments can be submitted on or before 12/14. To view the notice, click here.
Drugs
FDA says its lab findings again link Rugby Diocto’s oral liquid docusate sodium to Burkholderia cepacia. The contamination was confirmed in several bottles of Rugby Diocto (docusate sodium) oral liquid from lot No. 20351701 manufactured by PharmaTech (Davie, FL). The lot was collected by FDA in response to a
FDA Policy/General
Comments Sought on CVM Dispute Resolution Info Collection Federal Register notice: FDA seeks comments on an information collection extension about a guidance on dispute resolution procedures for CVM regulatory decisions. 10/27/2017 Draft Guide on Generic Drug User Fees Federal Register notice: FDA releases a draft guidance on “Assessing
FDA Policy/General
Federal Register notice: FDA seeks comments on an information collection extension about a guidance on “Dispute Resolution Procedures for Science-Based Decisions on Products Regulated by CVM — 21 CFR Section 10.75.” To view the notice, click here.
FDA Policy/General
FDA has released a draft guidance on “Assessing User Fees Under the Generic Drug User Fee Amendments of 2017.” The document outlines changes to the generic drug user fee program when it was recently reauthorized. It provides an explanation about the new fee structure and types of fees for which
FDA Policy/General
Federal Register notice: FDA has made available a draft guidance entitled “Pediatric Gastroesophageal Reflux Disease: Developing Drugs for Treatment.” The document is intended to assist sponsors in the clinical development of drugs for treating this condition. It includes a discussion of clinical presentation by age and disease, study populations, endpoints,
Drugs
FDA has accepted for priority review an AbbVie NDA for elagolix, an investigational, orally administered gonadotropin-releasing hormone (GnRH) antagonist for managing endometriosis with associated pain. The NDA is supported by data from randomized clinical trials involving nearly 1,700 women with moderate-to-severe endometriosis-associated pain. The company
Devices
FDA has cleared a Butterfly Network 510(k) for what the sponsor describes as the world’s first “ultrasound-on-a-chip” based imaging system, the Butterfly iQ for the iPhone. The clearance covers 13 clinical applications, the “broadest ever for a single ultrasound transducer,” the company says. “By combining
Devices
FDA has posted a guidance on “De Novo Classification Process (Evaluation of Automatic Class III Designation)” that provides recommendation on how to use the process to get a device classified and on the market. The pathway is intended for sponsors that believe their device is appropriate for classification into Class
Devices
FDA has issued a final guidance document entitled “Manufacturers Sharing Patient-Specific Information from Medical Devices with Patients upon Request.” The document clarifies that agency requirements do not prohibit manufacturers from sharing patient-specific information recorded, stored, processed, retrieved, or derived from a medical device with the patient who is
FDA Policy/General
Federal Register: FDA is seeking comments on an information collection extension related to a guidance on “Formal Dispute Resolution: Scientific and Technical Issues Related to Pharmaceutical Current Good Manufacturing Practice.” To view the notice, click here.
Devices
FDA has released a guidance entitled: “Product Labeling for Certain Ultrasonic Surgical Aspirator Devices” that describes the agency’s current thinking on such devices’ labeling and makes recommendations. The devices are commonly used in procedures to break down, liquefy, and remove hard and soft tissue. “Although the agency is not
Drugs
Legislation introduced by four congressional Democrats would direct HHS to negotiate with drug manufacturers for lower prices on covered Medicare Part D drugs. Rep. Lloyd Doggett (D-TX), the bill’s prime sponsor, says drug pricing in the U.S. “is a tangled mess, a knot that will take more
Devices
FDA has cleared a Nitiloop 510(k) for the Nova Cross Extreme and Nova Cross BTK, dedicated microcatheters for use in conjunction with conventional guidewires to access discrete regions of the coronary and peripheral vasculature. The low profile micro-catheters use an expandable nitinol scaffold shaped like a loop located
Drugs
FDA has approved a Tesaro supplemental NDA for Varubi (rolapitant) IV in combination with other antiemetic agents in adults for preventing delayed nausea and vomiting associated with initial and repeat courses of emetogenic cancer chemotherapy, including highly emetogenic chemotherapy. Delayed nausea and vomiting can occur anytime between 25 and 120
FDA Policy/General
Federal Register notice: FDA has made available a guidance entitled “Deciding When to Submit a 510(k) for a Change to an Existing Device” that clarifies when a change in a legally marketed medical device would require a 510(k) submission. The document supersedes a similar guidance issued in 1997.
Drugs
Achaogen has submitted an NDA for plazomicin, indicated for treating complicated urinary tract infections, including pyelonephritis and bloodstream infections due to certain Enterobacteriaceae in patients who have limited or no alternative treatment options. The submission includes data from the EPIC and CARE clinical trials which evaluated the safety and efficacy