Drugs
Fagron Sterile Services has recalled two lots of neostigmine methylsulfate 5ml syringes after a confirmed customer complaint that some syringe units are incorrectly labeled as neostigmine methylsulfate 1mg/ml, 3mg per 3ml. “In the event that 5ml rather than the intended 3ml is administered to a patient, adverse events from
Drugs
Drawing from a Science article, The BMJ says the FDA drug approval process “may be tainted by financial conflicts of interest with drug companies that are based not only on present and past ties, but also on future ones that may be created. The BMJ’s post says the Science
Drugs
A 10/23-10/27/17 FDA inspection at Sichuan Friendly Pharmaceutical Co., Sichuan, China, found significant deviations from current good manufacturing practice (CGMP) regulations for active pharmaceutical ingredients. A 6/22 Warning Letter says the specific deviations were: * failing to ensure that all specifications and test procedures are scientifically
Drugs
Two Hyman, Phelps, and McNamara attorneys say the Justice Department (DoJ) is quietly implementing a policy asking that various law enforcement entities appropriately coordinate in imposing penalties on a company, to “avoid the risk of repeated punishments that may exceed what is necessary to rectify the harm and deter future
Drugs
Rep. Frank Pallone (D-NJ), ranking Democrat on the House Energy and Commerce Committee, says the committee should hold a hearing to examine misuse of the FDA Risk Evaluation and Mitigation Strategies (REMS) program by drug companies looking to block, impede, or delay generic competitors from coming to market. In
Drugs
FDA has cleared an Oculocare Medical 510(k) for Alleye, a mobile medical software application indicated for detecting and monitoring age-related macular degeneration (AMD). The device is designed to detect and characterize central and paracentral metamorphopsia (visual distortion) in patients with macular conditions including AMD and diabetic retinopathy. After
Drugs
An 8/15-8/18/17 FDA inspection at Foshan Jinxiong Technology, Foshan City, China, found significant violations of current good manufacturing practice (CGMP) regulations for finished pharmaceuticals, according to a 6/26 Warning Letter. Specific violations noted in the letter, were: * failing to have, for each batch of drug
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,
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
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
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
Drugs
Generic drug stakeholders have recommended regulatory science research topics for FDA to pursue in Fiscal Year 2019. The Association for Accessible Medicines suggests: orally inhaled products, in-vitro methods, biowaivers, global reference product, CQAs, human factors considerations for sameness, identifying in-vitro alternatives to clinical endpoint studies, assessment of suitability
Drugs
Members of the FDA Anesthetic and Analgesic Drug Products Advisory Committee and the agency’s Drug Safety Advisory Committee have voted 14-3 to recommend that FDA not approve Pain Therapeutics’ Remoxy ER (oxycodone extended-release capsules) for management of pain severe enough to require daily, around-the-clock, long-
Drugs
FDA has released the FDA-483s issued following an agency 3/26-3/30 inspection at one Galaxy Surfactants manufacturing facility in Tarapur, India, and a 3/19-3/23 inspection at a second manufacturing facility in the same city. Observations from the first report were: * responsibilities and procedures applicable
Drugs
FDA has released the FDA-483 issued to Exela Pharma Sciences, a Lenoir, NC, outsourcing facility, following a 9/19-9/28/17 inspection. Specific observations on the form were: * failing to handle and store components and drug product containers at all times in a manner to prevent contamination; * aseptic
Drugs
FDA has granted Revive Therapeutics an orphan drug designation for cannabidiol (CBD) for treating autoimmune hepatitis (AIH), a rare disease that causes inflammation to the liver. The current standard of care is the use of steroids alone or steroids combined with azathioprine, which can cause severe treatment-related side effects
Drugs
Global Blood Therapeutics say it is in discussions with FDA about accelerated approval for its voxelotor to treat sickle cell anemia based on results from Part A of its Phase 3 HOPE (Hemoglobin Oxygen Affinity Modulation to Inhibit HbS PolymErization) study that showed a statistically significant increase in the proportion