Drugs
FDA has approved a Novartis NDA for Tafinlar (dabrafenib) and Mekinist (trametinib) for the combination treatment of anaplastic thyroid cancer that cannot be removed by surgery or has spread to other parts of the body. The approval covers the drugs’ use in patients that have a type of abnormal gene,
FDA Policy/General
Federal Register notice: FDA has withdrawn three Sun Pharmaceutical Industries ANDAs because they are no longer marketed. To view the notice, click here.
FDA Policy/General
Federal Register notice: FDA has withdrawn the approval of nine ANDAs from multiple applicants. The application holders have notified the agency that the drug products were no longer marketed and requested that they be withdrawn. To view the notice, click here.
FDA Policy/General
Federal Register notice: FDA has issued a final order to reclassify the needle destruction device into Class 2 (special controls)and subject to premarket notification. The device has been renamed “sharps needle destruction device.” To view the notice, click here.
Devices
FDA has cleared a PeraHealth 510(k) for the PeraTrend, a predictive, real-time clinical surveillance technology. “PeraHealth solutions are powered by the Rothman Index (RI), a comprehensive measure of a patient’s condition for healthcare providers, leveraging data within a hospital’s existing electronic health record (EHR) to quantify
Devices
CDRH is proposing a complete overhaul of its medical device review, safety surveillance and compliance structure to move to a more total product lifecycle (TPLC) approach to its decision making. Speaking at the Food and Drug Law Institute’s annual meeting in Washington, DC 5/3, CDRH director Jeff Shuren
Drugs
FDA has released the FDA-483 issued following a 12/4-12/12/17 inspection at Akorn AG, Zurich, Switzerland, a finished drug product manufacturer. The four inspection observations were: * failing to establish and document the accuracy, sensitivity, and reproducibility of test methods; * separate or defined areas to prevent contamination
Drugs
FDA has issued a document answering what it says are questions frequently asked by industry about the agency’s clinical data summary pilot program. Questions are answered on what parts of a clinical study report FDA will make available, who redacts information and how that process operates, and who to
Drugs
FDA has released the FDA-483 issued following a 4/17-4/25 inspection at Infuscience, an Eagan, MN, producer of sterile drug products. Inspection observations shown on the form were: * visibly dirty equipment or surface in the ISO 5 classified aseptic processing area; * · personnel moved rapidly in the vicinity
Drugs
Approval times for generic drugs dropped significantly from the first quarter of the fiscal year (10/2017-12/2017) to the second quarter (1/2018-3/2018), according to CDER’s latest Activities Report of the Generic Drugs Program. The quarterly performance report shows that the mean tentative approval time
Devices
FDA has issued a final order, General Hospital and Personal Use Devices: Reclassification of Sharps Needle Destruction Device, reclassifying the needle destruction device from Class 3 to Class 2 and renaming the device type to “sharps needle destruction device.” An agency notice says a sharps needle destruction device is an
FDA Policy/General
FDA commissioner Scott Gottlieb continues to use his bully pulpit to rail against the pharmaceutical industry and its increasing drug costs for American consumers. While the agency has a minimal role in impacting drug costs outside of fostering competition in the generic drug space, Gottlieb nevertheless took the opportunity during
FDA Policy/General
Federal Register notice: FDA has made available a final guidance entitled “Assessing User Fees Under the Prescription Drug User Fee Amendments of 2017.” The document addresses FDA’s implementation of the Prescription Drug User Fee Amendments of 2017 (PDUFA VI) and certain changes in policies and procedures surrounding its application.
Drugs
FDA has issued a complete response letter to Sandoz for its BLA for a biosimilar of rituximab (Genentech’s Rituxan), indicated for treating some non-Hodgkin’s lymphomas. The company says it stands behind “the robust body of evidence included in the regulatory submission and is currently evaluating the content
Drugs
FDA has reached an agreement with Alnylam Pharmaceuticals on elements of a Phase 3 study for its lumasiran, an investigational RNAi therapeutic for treating primary hyperoxaluria type 1 (PH1). The company says it and the agency have agreed on a study size of about 25 patients with PH1 and a
Drugs
FDA has issued a guidance, Assessing User Fees Under the Prescription Drug User Fee Amendments of 2017, describing the types of user fees authorized by PDUFA 6, the process for submitting payments to FDA, the consequences for failing to pay application fees or prescription drug program fees, and the process
Drugs
The DC District Court has ruled in FDA’s favor to dismiss a suit by the Center for Responsible Science (CRS) that sought new warnings on informed consent documents used in clinical trials. The lawsuit asked the court to force the agency to grant a CRS 6/2014 citizen petition
Drugs
FDA has released the FDA-483 with four observations issued following a 4/16-4/20 inspection at QuVa Pharma, a Temple, TX, drug outsourcing facility. Specific inspection observations were: * the quality control unit lacks authority to fully investigate errors that have occurred; * written records of investigations of a drug
Drugs
FDA says that one dose of InfaCare Pharmaceutical’s stannsoporfin to treat neonates who are at high risk for developing serious complications related to severe hyperbilirubinemia significantly reduced bilirubin levels, but could lead to long-term neurological risk. The assessment is in a briefing document prepared in advance of a
Devices
NPR and Side Effects Public Media say their investigation into Innovative Health Solutions’ Bridge medical device being used for opioid withdrawal found that FDA approved the device indication based on results from a clinical trial that was inaccurately described as a retrospective study. The report says the device had been
Drugs
FDA has granted Bavarian Nordic an orphan drug designation for its BN-Brachyury vaccine for treating chordoma, a rare cancer that develops along the spine. A Phase 2 study in patients with metastatic chordoma will begin in the second half of this year, enrolling up to 25 patients. An open-
FDA Policy/General
FDA has approved Bausch + Lomb’s Ultra contact lenses for extended wear for up to six nights and seven days of continuous wear. The contact lenses include the company’s MoistureSeal technology, a patented combination of material and manufacturing process that helps to maintain 95% of lens moisture for 16