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
Drugs
FDA has completed a pre-approval inspection of the Biocon sterile drug manufacturing facility in Bangalore, India, and issued an FDA-483 with seven inspection observations. In a filing with the National Stock Exchange of India, Biocon says the inspection observations “are largely procedural and aimed at continuous improvement.” It
Drugs
A Fresenius decision last month to terminate the company’s $4.7 billion merger agreement with generic drug company Akorn was based on alleged “blatant fraud at the very top level” at Akorn, Fresenius said in a recent court filing. Last month, Fresenius said its decision was based on, among
Devices
FDA has approved a Medtronic PMA for its Deep Brain Stimulation (DBS) therapy as adjunctive treatment for reducing the frequency of partial-onset seizures, in individuals 18 years of age or older who are refractory to three or more antiepileptic medications. “DBS therapy for epilepsy delivers controlled electrical pulses to
Drugs
The 7th Circuit Court of Appeals issued in March a powerful endorsement of the learned intermediary doctrine in multi-district litigation involving a Zimmer knee implant. Attorney Jonah Knobler (Patterson Belknap) writes in a Washington Legal Foundation Legal Opinion Letter that the court rejected arguments saying that the learned intermediary
Drugs
Karyopharm Therapeutics says it will submit an NDA in the second half of this year for selinexor for multiple myeloma after reporting positive top-line results from the Phase 2b STORM study. Data from the study showed that selinexor achieved a 25.4% overall response rate (ORR), which included two
Devices
FDA has cleared a Conavi Medical 510(k) for its Novasight Hybrid System, which allows simultaneous imaging of coronary arteries with both intravascular ultrasound and optical coherence tomography. Such imaging is typically used by interventional cardiologists to image coronary anatomy during angioplasty and stenting procedures, the company says. The device
Drugs
FDA has approved a Novartis NDA for Tafinlar (dabrafenib) in combination with Mekinist (trametinib) for the adjuvant treatment of patients with melanoma with BRAF V600E or V600K mutations, and involvement of lymph nodes, following complete resection. Approval was based on data from COMBI-AD, a Phase 3 study of 870
Drugs
A 3/13-3/23/17 FDA inspection at Fusion IV Pharmaceuticals, a Los Angeles, CA, 503B outsourcing facility doing business as Axia Pharmaceuticals, found multiple violations, including that drug products produced by the firm failed to meet the conditions of Section 503B of the Federal Food, Drug, and Cosmetic