Drugs
The Center for Science in the Public Interest (CSPI) says FDA should send Warning Letters to companies marketing 39 dietary supplements that explicitly or implicitly claim to treat female infertility because they are being marketed as unapproved and/or misbranded drugs. In an 11/18 letter, CSPI says the products’
Drugs
Bristol-Myers Squibb and Celgene say they will divest Celgene’s psoriasis drug Otezla to Amgen for $13.4 million to settle Federal Trade Commission (FTC) charges that Bristol-Myers Squibb’s proposed $74 billion acquisition of Celgene would violate federal antitrust law. The commission has said that, as proposed,
Devices
CDRH Office of Product Evaluation and Quality technical guidance specialist Jason Ryans says the purpose of the new safety and performance-based pathway is to establish a voluntary more modern 510(k) pathway for demonstrating safety and effectiveness for certain well-understood devices. Speaking during a CDRH 11/7 Webinar,
Biologics
FDA has accepted for review a Samsung Bioepis BLA for SB8, a biosimilar candidate referencing Genentech’s Avastin (bevacizumab). Avastin is indicated for treating five types of cancer: metastatic colorectal cancer; unresectable, locally advanced, recurrent or metastatic non-squamous non-small cell lung cancer; recurrent glioblastoma; metastatic renal cell carcinoma;
Devices
An FDA device safety update about intra-aortic balloon pumps by Getinge’s Maquet/Datascope shutting down while running on battery power says the agency has received dozens more reports since an 11/2018 alert was issued. The malfunction can lead to the pumps’ stoppage and loss of hemodynamic support,
Drugs
FDA has sent Nascent Biotech an untitled letter objecting to promotional content on the company’s Web site about its investigational drug pritumumab. The letter says that discussing the drug’s safety and effectiveness for the purpose for which it is being investigated misbrands the product. FDA says the Web
Drugs
FDA has issued a final guidance entitled “Smallpox (Variola Virus) Infection: Developing Drugs for Treatment or Prevention.” The document is intended to serve as a focus for continued discussions among the Division of Antiviral Products, pharmaceutical sponsors, the academic community, and the public. It focuses on drugs that are expected
FDA Policy/General
Federal Register notice: FDA has withdrawn ANDA approvals for two fentanyl transdermal systems held by Mayne Pharma Group and Actavis Laboratories. The drug products are both transdermal systems designed with a liquid reservoir. The companies have both requested withdrawal of their respective applications and have waived their opportunity for a
Devices
FDA’s Immunology Devices Panel of the Medical Devices Advisory Committee last week recommended that FDA should require dentists to move away from using mercury-containing amalgams and towards non-mercury containing products like composite materials when conducting dental restoration procedures. The panel agreed that FDA’s latest literature review
Devices
FDA has approved a Cerapedics PMA supplement for i-FACTOR Peptide Enhanced Bone Graft in anterior cervical discectomy and fusion procedures in patients with degenerative cervical disc disease. Cerapedics’ submission requested approval for an updated package insert that incorporates the 24-month follow-up data from subjects enrolled in the
Devices
CDRH has established a “Patient and Caregiver Connection” program to obtain feedback from these stakeholders on their experiences living with a condition or using medical devices. Certain partner organizations collect feedback on specific issues from their members and share that feedback with CDRH. “This patient feedback on the impact of
Devices
FDA has approved CooperVision’s MiSight, the first contact lens indicated to slow the progression of myopia (nearsightedness) in children between the ages of eight and 12 years old. The single use, disposable, soft contact lens is intended to be discarded at the end of each day, and is not
Drugs
FDA has granted Levo Therapeutics a fast track designation for LV-101 (intranasal carbetocin) for treating Prader-Willi syndrome (PWS). Levo is currently enrolling patients in a Phase 3 clinical study (CARE-PWS) of intranasal carbetocin for the indication. The study has an eight-week period designed to test the
Biologics
FDA has hit a milestone with the approval of Pfizer’s Abrilada (adalimumab - afzb), a biosimilar to AbbVie’s Humira, which is the 25th biosimilar product approved since 2010 when Congress gave the agency authority to approve biologic product knockoffs. Abrilada is indicated for treating rheumatoid arthritis, juvenile idiopathic arthritis,
FDA Policy/General
Proposal to Withdraw 4 NDAs Federal Register notice: FDA proposes to withdraw approval of four NDAs from multiple NDA holders because they have repeatedly failed to file required annual reports. 11/15/2019 OTC Drugs Panel Charter Renewal Federal Register notice: FDA announces the renewal of the Nonprescription Drugs Advisory
FDA Policy/General
StemCutis, LLC says the Naval Medical Center San Diego has been added as a second site for the Phase 2 portion of its clinical trial for subjects with cutaneous photoaging, a skin condition caused by chronic ultraviolet radiation sun exposure. According to the company, the clinical trial combines low-dose
FDA Policy/General
Federal Register notice: FDA is proposing to withdraw approval of four NDAs from multiple NDA holders because they have repeatedly failed to file required annual reports. The NDAs are: * NDA 014217 Maolate (chlorphenesin carbamate) tablets, 400mg (Pan American Laboratories) * NDA 018663 Chymodiactin (chymopapain) for Injection, 4,000 Units/vial and
FDA Policy/General
Federal Register notice: FDA has announced the renewal of the Nonprescription Drugs Advisory Committee for an additional two years beyond the charter expiration date. The new charter will be in effect until 8/27/2021. To view the notice, click here.
FDA Policy/General
Federal Register notice: FDA has submitted to OMB an information collection extension for “Q-Submission Program for Medical Devices” (OMB Control Number 0910-0756). The collection concerns a guidance entitled “Requests for Feedback and Meetings for Medical Device Submissions: The Q-Submission Program” and provides an overview of the mechanisms
FDA Policy/General
Federal Register notice: FDA is seeking comments on an information collection extension for “Testing Communications on Medical Devices and Radiation-Emitting Products” (OMB Control Number 0910-0678). Agency regulations permit it to conduct educational and public information programs relating to the safety of regulated medical devices and radiation-emitting products.
Drugs
Generic drug companies have had mixed results from FDA efforts to help them get timely samples from brand-name companies for bioequivalence testing, according to a new Government Accountability Office (GAO) report. One on the most notable delays occurs with brand products where FDA has required risk evaluation and mitigation
Drugs
FDA’s Endocrinologic and Metabolic Diseases Advisory Committee has voted 16 to 0 to recommend approval for Amarin’s submission to expand Vascepa’s (icosapent ethyl) indication to reduce the risk of cardiovascular events as an adjunct to statin therapy in adults with elevated triglycerides and other cardiovascular disease risk