Drugs
Cantrell Drug Co. says it is recalling all lots of unexpired sterile drug products to the hospital and user level due to lack of sterility assurance. FDA has published a Cantrell news release on the recall. The company says the recalled products were distributed to healthcare facilities nationwide except for
Drugs
FDA has posted its latest batch of Warning Letters. They can be accessed by clicking on the link following each letter. Option Care Enterprises, Columbia, MD (7/20): FDA inspected the firm in June and cited serious deficiencies with its sterile drug production. The agency noted that drug products intended
Drugs
FDA has issued a guidance entitled “IRB Waiver or Alteration of Informed Consent for Clinical Investigations Involving No More Than Minimal Risk to Human Subjects.” The document provides recommendations on FDA enforcement of regulations governing informed consent requirements for clinical investigations that involve no more than minimal risk to human
Drugs
FDA has issued a revised International Council for Harmonization guidance on “M4E(R2): The CTD — Efficacy.” The document provides recommendations for applicants preparing the Common Technical Document (CTD) for submissions to the agency. It presents the agreed-upon common format that will be accepted in the ICH regulatory regions for
Drugs
FDA has accepted for review a Spectral Medical rolling PMA for Toraymyxin, indicated for treating patients with septic shock. Toraymyxin is described by the company as a polymyxin B extracorporeal direct hemoperfusion adsorption column that is effective in removing endotoxin in the bloodstream. Toraymyxin has been approved and marketed by
Drugs
FDA has approved a Teligent ANDA for generic erythromycin topical gel, an antibiotic for treating skin infections. Based on recent QuintilesIMS Health data from 5/2017, the market for this product is about $17.6 million. Teligent has 19 topical generic pharmaceutical products in its U.S. portfolio.
Drugs
A House Judiciary subcommittee has announced a 7/27 hearing on “Antitrust Concerns and the FDA Approval Process.” The hearing is scheduled for 1:00pm and no witness confirmations have been announced yet. Congress recently has been expressing concern about high prescription drug prices, which some attribute to brand drug
Drugs
FDA has approved a GlaxoSmithKline supplemental BLA for a new subcutaneous formulation of Benlysta (belimumab) for treating adult patients with active, autoantibody-positive Systemic Lupus Erythematosus (SLE) who are receiving standard therapy. SLE is the most common form of lupus, a chronic, incurable autoimmune disease. “After training from their health
Drugs
FDA has launched a new tool to help patients seeking expanded access to investigational drugs when there are no alternatives for seriously ill patients. The Expanded Access Navigator is an online tool created under a collaboration including the Reagan-Udall Foundation, pharmaceutical industry, FDA, and others in government. Expanded Access
Drugs
FDA has accepted a Bristol-Myers Squibb supplemental BLA to update Opdivo (nivolumab) dosing to include 480 mg infused over 30 minutes every four weeks for all currently approved monotherapy indications. The agency has set a user fee review action (XXX DELETE XX)date of 3/5/2018. Opdivo is
Drugs
3 Public Meetings on Drug Distribution Federal Register notice: FDA announces three public meetings entitled “Enhanced Drug Distribution Security Under the Drug Supply Chain Security Act.” 07/21/2017 Comments on Unapproved Animal Drugs for Minor Species Listing Federal Register notice: FDA seeks comments on an information collection extension on
Drugs
FDA has granted Merck tentative approval for Lusduna Nexvue (insulin glargine injection) 100 units/mL, a follow-on biologic basal insulin in a pre-filled dosing device. The proposed product is being developed by Merck with funding from Samsung Bioepis. “With the tentative approval, Lusduna Nexvue has met all required
Drugs
Oscor Inc. has recalled certain lots of its ATAR Extension Cable due to a risk of them separating from the connectors during use. The extension cable intended to connect an electrode/lead from a patient or another cable to a diagnostic machine or an external pacemaker. “Detachment of the extension
Drugs
FDA has accepted for review a Churchill Pharmaceuticals NDA for Yonsa (abiraterone acetate) ultramicrosize tablets for treating metastatic castration-resistant prostate cancer. The agency has set a 3/19/2018 user fee review action target date. The submission was based on data from the STAAR study, a randomized, open label
Drugs
Med Prep Consulting president Gerald Tighe and pharmacy director Stephen Kalinoski pleaded guilty 7/14 to wire fraud conspiracy regarding distributing cancer drugs contaminated with mold. Their company was a medical drug repackager and compounding pharmacy. The Justice Department and FDA Office of Criminal Investigations say that Med Prep processed
Drugs
FDA released the FDA-483 containing 14 observations from a 4/26-5/10 inspection at Intas Pharmaceutical, a Ahmedabad, Gujarat, India, biosimilar sterile drug manufacturer. The observations were: * laboratory records are deficient in that they do not include a complete record of all data obtained during testing; * appropriate controls
Drugs
CDER Office of Compliance deputy director Ilisa Bernstein says FDA has led a team of international partners for the last four years in creating the Supply Chain Security Toolkit for Medical Products. Writing in an FDA Voice blog post, Bernstein says that collaborators included regulators from the 21-nation Asia-
Drugs
Pharmaceutical Manufacturing Research Services (PMRS) is asking FDA not to approve a pending Intellipharmaceutics NDA for oxycodone hydrochloride extended-release tablets with a proposed indication of “management of moderate-to-severe pain when a continuous around-the-clock analgesic is needed for an extended period of time.” The PMRS petition
Drugs
The 21st Century Cures Act contains provisions intended to facilitate development of medical countermeasure (MCM) products. In a Web site post, FDA outlines the provisions and their effect on product development. Examples of the provisions cited are: encouraging complex adaptive and other novel trial designs, fostering potential use of real-
Drugs
FDA commissioner Scott Gottlieb has outlined new approaches the agency will implement to help speed up generic drug reviews and approvals. Speaking at a 7/19 meeting on Hatch-Waxman Amendments and whether appropriate balance is still maintained between brand and generic companies since the law was enacted in 1984,
Drugs
Three industry trade groups are reiterating their opposition to a proposed FDA final rule defining the intended use of a drug or medical device based on the totality of the evidence rather than on a manufacturer’s promotional claim for the product, which is the current practice. In 7/18
Drugs
FDA says that based on stability data provided by Pfizer and reviewed by the agency, the company’s Hospira sodium bicarbonate injection, USP 8.4%, 50 mEq/50mL single dose glass fliptop vial has extended use dates by lot number. It is the latest update on Hospira drugs in shortage