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FDA has issued a draft guidance, Major Depressive Disorder: Developing Drugs for Treatment, to aid sponsors in clinical development of drugs for the monotherapeutic, combination, and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.
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
FDA Policy/General
Federal Register notice: FDA has published a list of information collections that have been approved by the Office of Management and Budget under the Paperwork Reduction Act of 1995. To view the notice, click here.
FDA Policy/General
Federal Register notice: FDA has made available a draft guidance entitled “S9 Nonclinical Evaluation for Anticancer Pharmaceuticals — Questions and Answers.” The ICH document is intended to provide additional clarity about anticancer pharmaceutical development described in the ICH guidance “S9 Nonclinical Evaluation for Anticancer Pharmaceuticals” that was published in 2010. To
Devices
FDA has cleared a B. Braun Medical 510(k) for its wireless second generation software for its Perfusor Space Syringe Pump. This is the first syringe pump with air and road transport in its cleared indications for use, according to the company. It is also integrated with DoseTrac, DoseGuard, and
Drugs
CDER deputy director for regulatory programs Douglas Throckmorton says IV fluid shortages that have existed since 2014 and were exacerbated by Hurricane Maria’s effect on Puerto Rican drug manufacturers in 2017 are finally easing. An agency news release says that “after much work and a great deal of collaboration
Drugs
Pharmaceutical Research and Manufacturers of America (PhRMA) says that while it supports continued development of targeted therapies for molecularly defined conditions, it is important to avoid unintended consequences that might adversely affect orphan drug development. “If the incentives for development of products shift away from tumor histology to tissue agnostic
Drugs
FDA has lifted a clinical hold against Solid Biosciences’ Phase 1/2 clinical trial for its investigational microdystrophin gene transfer, SGT-001, for treating Duchenne muscular dystrophy. In its letter, the agency acknowledged that the company satisfactorily addressed all clinical hold questions. Solid Biosciences has begun activities to resume the
Devices
FDA has cleared an Arcuro Medical 510(k) for its SuperBall meniscus repair system. The all-suture device is intended to preserve knee functionality and features “no knot in the joint space,” according to the company. Arcuro says it expects to convert a significant portion of the meniscus removal procedures
Drugs
FDA has issued a clinical hold on a Ziopharm Oncology Phase 1 trial to evaluate CD19-specific CAR-T therapies manufactured under point-of-care, and requested additional information to support the IND. The clinical trial is intended to evaluate CAR T cells manufactured with “Sleeping Beauty” technology as an