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Federal Register notice: FDA has made available a draft guidance entitled “Cancer Clinical Trial Eligibility Criteria: Minimum Age for Pediatric Patients.”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
Drugs
FDA has granted Purdue Pharma a fast track designation for nalmefene hydrochloride injection, an investigational opioid antagonist for the emergency treatment of known or suspected opioid overdose. Nalmefene has a longer duration of effect than naloxone, another opioid antagonist currently approved for opioid overdose, the company says. The agency designation
FDA Policy/General
Federal Register notice: FDA has made available a draft guidance entitled “Cancer Clinical Trial Eligibility Criteria: Brain Metastases.” The document provides recommendations on the inclusion of patients with brain metastases in cancer trials. It notes that patients with brain metastases have historically been excluded from clinical trials due to concerns
FDA Policy/General
Federal Register notice: FDA has made available a final guidance entitled “Considerations for the Inclusion of Adolescent Patients in Adult Oncology Clinical Trials.” The document focuses on appropriate patient selection criteria at various stages of drug development, considerations for dosing and pharmacokinetic evaluations, safety monitoring, and ethical considerations. To view
Drugs
FDA has just released the FDA-483 issued following a 6/14-8/1/18 inspection at Immunomedics, a Morris Plains, NJ, clinical trial sponsor. The four observations were: * not all participating investigators were informed of new observations discovered by or reported to the sponsor; * failing to ensure proper monitoring
FDA Policy/General
Federal Register notice: FDA has made available a draft guidance entitled “Cancer Clinical Trial Eligibility Criteria: Patients with Organ Dysfunction or Prior or Concurrent Malignancies.” The document provides recommendations about the inclusion of patients with organ dysfunction or with prior or concurrent malignancies, which FDA says can maximize the generalizability
Drugs
Janssen Pharmaceutical has submitted a supplemental BLA for Darzalex (daratumumab) in combination with lenalidomide and dexamethasone for treating patients with newly diagnosed multiple myeloma who are ineligible for autologous stem cell transplant. The submission, which is based on data from the Phase 3 MAIA (MMY3008) clinical study, is being reviewed
Drugs
FDA has approved an Aerie Pharmaceuticals NDA for Rocklatan (netarsudil and latanoprost) ophthalmic solution, 0.02/0.005% to reduce elevated intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension. Approval is based on data from two Phase 3 studies, MERCURY 1 and MERCURY 2, with Rocklatan
Devices
CDRH is implementing a reorganization that will combine the Office of Compliance, Office of Device Evaluation, Office of Surveillance and Biometrics, and the Office of In Vitro Diagnostics and Radiological Health into one super office — Office of Product Evaluation and Quality. It will be focused on a “Total Product Life
Drugs
A New York federal judge has denied a Teva motion for summary judgment in a whistleblower case over speakers bureau promotion of two of its drugs. In the case, former Teva sales representatives allege that the speaker program for the firm’s Azilect (rasagiline) tablets, a Parkinson’s disease drug,
Drugs
FDA has issued five new guidances intended to encourage a broadening of eligibility criteria to allow more people participating in clinical trials of drugs and biological products for treating cancer, including patients with HIV, HBV, HCV, organ dysfunction, and prior or concurrent malignancies and brain metastases. The agency says that
Drugs
A Texas federal judge has entered a consent decree ordering Guardian Pharmacy Services, a Dallas drug compounder, to stop producing compounded drug products intended to be sterile until the company complies with the Federal Food, Drug, and Cosmetic Act and other requirements. An FDA news release says that despite receiving
FDA Policy/General
Federal Register notice: FDA is correcting a 12/13/2018 notice entitled “Data Integrity and Compliance With Drug CGMP: Questions and Answers; Guidance for Industry; Availability” because it was published with the incorrect docket number. The corrected docket is “FDA–2016–D–1113.” To view the notice, click here.
FDA Policy/General
Federal Register notice: FDA is seeking comments on an information collection extension for “Information To Accompany Humanitarian Device Exemption Applications and Annual Distribution Number Reporting Requirements” (OMB Control Number 0910-0661). To view the notice, click here.
FDA Policy/General
Federal Register notice: FDA is seeking comments on an information collection extension for “Evaluation of the Program for Enhanced Review Transparency and Communication for New Molecular Entity New Drug Applications and Original Biologics License Applications in Prescription Drug User Fee Acts and 351(k) Biologics License Applications in Biosimilars User