Devices
FDA has approved the Senseonics Eversense continuous glucose monitoring system for use in people age 18 and older with diabetes. The agency says it is the first such device approved with a fully implantable sensor to detect glucose that can be worn for up to 90 days. According to the
Drugs
In a disclosure reminiscent of others over decades involving pharmaceutical marketing abuses of FDA-approved drugs with devastating side effects and lax FDA labeling enforcement, CBS Evening News 6/21 reported a former Purdue Pharma sales person’s allegation of scientifically unsubstantiated “pseudoaddiction” claims about the company’s blockbuster opioid
Drugs
FDA has issued Staar Surgical a close-out letter that lifts a Warning Letter dated 5/21/2014, a signal that the company has corrected all issues to the agency’s satisfaction. The company says that the action is the “result of a comprehensive remediation program that not only addressed
Drugs
FDA says it is issuing a draft guidance, Prescription Drug Act User Fee Waivers, Reductions, and Refunds for Drug and Biological Products, with recommendations to applicants planning to request a waiver or reduction in user fees. A Federal Register 6/21 notice says the draft revises a 9/2011 guidance.
Drugs
The DC federal court has granted summary judgment to Eagle Pharmaceuticals in its case challenging FDA’s denial of orphan drug exclusivity for the company’s Bendeka (bendamustine), which has been designated as an orphan drug and approved to treat two rare forms of cancer. FDA had argued that it
Devices
The Justice Department says a federal grand jury has indicted Theranos founder Elizabeth Holmes and the company’s former chief operating officer Ramesh Balwani on two counts of conspiracy to commit wire fraud and nine counts of wire fraud. A department news release says the charges stem from allegations that
FDA Policy/General
Federal Register notice: FDA is seeking comments on an information collection extension for its “Guidance for Industry: Adverse Event Reporting for Outsourcing Facilities Under Section 503B of the Federal Food, Drug, and Cosmetic Act” (OMB Control Number 0910-0800). To view the notice, click here.
Drugs
FDA has designated Acurx Pharmaceuticals’ lead antibiotic product candidate, ACX-362E, as a qualified infectious disease product. The designation was granted for the drug’s use in treating patients with Clostridium difficile infection. ACX-362E is being developed as a targeted, narrow spectrum oral antibiotic, and a Phase 1 clinical
FDA Policy/General
Federal Register notice: FDA has withdrawn the approval of five NDAs from multiple applicants. The NDA holders have notified the agency that the products are no longer marketed. To view the notice, click here.
Devices
FDA has cleared a TransMed7 510(k) for the SpeedBird platform of soft tissue biopsy devices. The platform is based on the company’s Zero5 work element that comprises a fused, single element constructed from three hypotubes and forming rotating twin cutter blades. “This element cores, severs, and provides a
Drugs
FDA says it has redesigned its drug shortage Web page to make it easy to use to quickly locate current drug shortages and other important information. “The new look and organization of content direct users to current information quickly while still providing access to important records and historical data,” an
Drugs
FDA has issued a draft guidance, Major Depressive Disorder: Developing Drugs for Treatment, to aid sponsors in clinical development of drugs for the monotherapeutic, combination, and adjunctive treatment of major depressive disorder. “Specifically,” the document says, “this guidance addresses FDA’s current thinking regarding the overall development program and clinical
Drugs
Several stakeholders are raising issues related to an FDA docket on quality considerations for metered dose inhaler and dry powder inhaler products. The Association for Accessible Medicines, representing generic drug interests, voices three key concerns: industry should be granted a transition period to comply with the new requirements; the agency
Drugs
Yale University researchers who looked at 92 expanded drug access programs registered at ClinicalTrials.gov over the last two decades say that the balance established by FDA and the drug industry between investigational new drug access and protection of patients from therapies without established safety could be compromised by policy
FDA Policy/General
FDA has posted its latest batch of Warning Letters. They can be accessed by clicking on the link following each letter. Biologique Recherche Suresnes, France (6/8): FDA inspected the firm 9/2017 and cited significant GMP violations for finished pharmaceuticals. For example, the firm failed to have, for each
Drugs
FDA commissioner Scott Gottlieb says the agency wants to build on success it has had in promoting robust generic drug entry with two new initiatives that are part of the 2019 budget request. Writing in an FDA Voice blog post, Gottlieb says the first initiative will create a Knowledge-aided
Drugs
A 9/18-9/22/17 FDA inspection at Biologique Recherche, Suresnes, France, found significant violations of current good manufacturing practice (CGMP) regulations for finished pharmaceuticals, according to a 6/8 Warning Letter. Specific violations noted in the letter were: * failing to have, for each batch of drug product, appropriate
Devices
FDA has approved two Grifols blood screening assays: Procleix Ultrio Elite and Procleix WNV. Procleix Ultrio Elite is an assay that allows for increased blood safety by screening and delivering simultaneous results for human immunodeficiency virus Type 1, hepatitis C virus, and hepatitis B virus as well as detecting HIV
Devices
FDA says it is seeking public input and comment on an updated version of its software precertification program working model. An update notice (contains links to the updated working model, the comment docket, and other resources) says the new version outlines these pre-certification program key components: Excellence Appraisal and
Devices
FDA says it continues to evaluate information from several sources, including endovascular graft system manufacturers, about the risks associated with Type III endoleaks with various aortic endovascular graft systems indicated for treating abdominal aortic aneurysms and aorto-iliac aneurysms. In 9/2017, an FDA letter to health care providers alerted
Drugs
A New Jersey federal court has approved Indivior’s request for a temporary restraining order to stop Dr. Reddy’s Laboratories from launching its generic form of Indivior’s Suboxone (buprenorphene and Naloxone sublingual film) opioid disorder medication. Media accounts indicate that the order will remain in place until a
Drugs
A bipartisan group of 31 senators has written to FDA commissioner Scott Gottlieb asking that the agency’s Drug Shortage Task Force “work with stakeholders and federal agencies to determine the root causes of drug shortages and develop recommendations to ensure that appropriate supplies of essential medicines are always available.