Devices
FDA says that this fall it plans to hold an advisory committee meeting to discuss nitinol and other metals in device implants to understand the potential risk for certain patients with hypersensitivity or exaggerated immune and inflammatory reactions to the metals. “We’ve been exploring the link between immune and
Devices
An updated FDA safety alert on paclitaxel-coated products says that a preliminary data review has identified a potentially concerning signal of increased long-term mortality in study subjects compared to patients treated with uncoated devices. The study examined three trials with five-year follow-up data. “In total,"
Devices
FDA has cleared a Thornhill Research de novo marketing request for the ClearMate, intended to be used in an emergency room setting to help treat patients suffering from carbon monoxide poisoning. The device uses a novel method for quickly removing carbon monoxide from the body by increasing a patient’s
Biologics
Spectrum Pharmaceuticals has withdrawn a BLA for Rolontis (eflapegrastim), a treatment for chemotherapy-induced neutropenia in patients undergoing myelosuppressive chemotherapy, after FDA requested additional manufacturing-related information. The company says it plans to submit a revised BLA as soon as possible. FDA’s review did not cite concerns related to
Drugs
FDA has issued a draft guidance, A Risk-Based Approach to Monitoring of Clinical Investigations Questions and Answers, with guidance on risk-based approaches to monitoring investigational studies of human drugs and biological products, medical devices, and combinations. The document has recommendations on planning a monitoring approach, developing the content
Drugs
FDA has published a guidance, Enrichment Strategies for Clinical Trials to Support Determination of Effectiveness of Human Drugs and Biological Products, to increase the efficiency of drug development and support precision medicine. The document also discusses design options for enrichment strategies and discusses interpretation of the results of studies that
FDA Policy/General
Federal Register notice: FDA is seeking comments on an information collection extension for “Inspection by Accredited Persons Program Under the Medical Device User Fee and Modernization Act of 2002” (OMB Control Number 0910-0510). To view the notice, click here.
FDA Policy/General
Federal Register notice: FDA has published an updated “Modifications to the List of Recognized Standards, Recognition List Number: 051” that is intended to assist manufacturers who elect to declare conformity with consensus standards to meet certain requirements for medical devices. To view the notice, click here.
Drugs
Federal Register notice: FDA is seeking comments on an information collection extension for “Current Good Manufacturing Practice (CGMP) for Positron Emission Tomography Drugs” ( OMB Control Number 0910-0667). The CGMP requirements are designed according to the unique characteristics of PET drugs, including their short half-lives, and the fact that
Drugs
FDA has issued a guidance, Severely Debilitating or Life-Threatening Hematologic Disorders: Nonclinical Development of Pharmaceuticals, to assist sponsors in design of nonclinical studies for development of pharmaceuticals used to treat patients with severely debilitating or life-threatening hematologic disorders (SDLTHDS). The document says it is intended to streamline development
Devices
FDA has issued a guidance, Medical Devices Containing Materials Derived from Animal Sources (Except for In Vitro Diagnostic Devices), to update agency policy regarding use of animal-derived material in medical device manufacturing. “The role of animal-derived material in medical devices is well-established,” the document says. “However, these
FDA Policy/General
Federal Register notice: FDA has made available a draft guidance entitled “Cancer Clinical Trial Eligibility Criteria: Patients with HIV, Hepatitis B Virus, or Hepatitis C Virus Infections.” The document provides recommendations on including such patients because expanding cancer clinical trial eligibility to be more inclusive is justified in many cases,
FDA Policy/General
Federal Register notice: FDA has amended its animal drug regulations to reflect application-related actions for new animal drug applications and abbreviated new animal drug applications during July, August, and September 2018. The agency is making available summaries of the basis of approval and environmental review documents, where applicable. The
Drugs
FDA has issued Pharmaceutics International two Establishment Inspection Reports (EIRs) following routine and pre-approval inspections last October and November at the company’s non-sterile and sterile drug production facilities in Hunt Valley and Cockeysville, MD. The contract development and manufacturing organization was given “voluntary action indicated” status on
Devices
FDA has approved Biotronik’s Acticor and Rivacor high-voltage cardiac rhythm management (CRM) device lines for treating patients with cardiac arrhythmias. The devices are: Rivacor VR-T, Rivacor DR-T, Rivacor HF-T QP, Acticor DX, Acticor CRT-DX Bipolar and Acticor CRT-DX. They are designed with advanced
Devices
FDA has approved a new indication for the Abbott Vascular MitraClip for treating patients with normal mitral valves who develop heart failure symptoms and moderate-to-severe or severe mitral regurgitation because of diminished left heart function despite being treated with optimal medical therapy. An agency statement says the MitraClip
Drugs
FDA commissioner Scott Gottlieb says recent guidances are part of an effort to modernize clinical trials to take advantage of novel opportunities such as trials in which small groups of patients are selected based on biomarkers or other criteria suggesting they are likely to benefit. In a statement, Gottlieb says
Devices
FDA has approved a BD (Becton Dickinson) PMA for the Venovo venous stent, indicated for treating iliofemoral venous occlusive disease, which is obstructed or narrowed blood flow specific to the iliac and femoral veins located near the groin. The flexible nitinol stent is designed to reopen blocked iliac and femoral
Drugs
The Justice Department says that five individuals and two companies have pleaded guilty to felony charges in a multi-million-dollar scheme to fraudulently sell popular dietary supplements. The department says the pleas were entered in a Texas federal court acknowledging that the companies and individuals played roles in developing,
Drugs
Attorney and healthcare communications consultant Mark Senak (FleishmanHillard) says his analysis of CDER Office of Prescription Drug Promotion (OPDP) enforcement actions since 2004 shows that actions regarding promoting an unapproved drug have risen substantially, signaling that this is a current enforcement priority for OPDP. Writing in his Eye on FDA
FDA Policy/General
Federal Register notice: FDA has made available a draft guidance entitled “Cancer Clinical Trial Eligibility Criteria: Minimum Age for Pediatric Patients.” The document provides recommendations on the inclusion of pediatric patients in clinical trials for cancer treatments. To view the notice, click here.
Biologics
FDA has just released the FDA-483 issued following a 6/18-6/22/18 inspection at Genetech, a San Diego, CA, umbilical cord processing facility. The 10 inspection observations are: * the eligibility of an HCT/P donor was not determined and documented by a responsible person, based on results