Devices
FDA has cleared a Pelvalon 510(k) for its next generation Eclipse System for women suffering from loss of bowel control. According to the company, it is the first vaginal insert designed to provide immediate bowel control. The original version of the device was granted marketing clearance under the de
Drugs
FDA has postponed due to an expected snow storm a 1/22 Peripheral and Central Nervous System Advisory Committee meeting scheduled to review a Sarepta Therapeutics NDA for eteplirsen, indicated for treating Duchenne muscular dystrophy (DMD) amenable to exon 51 skipping. A future meeting date will be announced in the
FDA Policy/General
CDER’s Office of Prescription Drug Promotion (OPDP) says that a Hospira YouTube video for its Precedex (dexmedetomidine HCl) injection is false and misleading because it omits risks and material facts associated with the drug. A 1/14 Notice of Violation says the violations create “a misleading impression about the
Drugs
FDA has published a draft guidance, Best Practices for Communication Between IND Sponsors and FDA During Drug Development, outlining best practices and procedures for timely, transparent, and effective communications between IND sponsors and the agency at critical junctures in drug development. The document describes: FDA’s philosophy about timely interactive
Drugs
The Supreme Court has declined to review a DC Circuit Appeals Court decision in a seven-year antitrust dispute between the Federal Trade Commission (FTC) and Boehringer over questions concerning lawyers’ work-product protections. The National Law Journal reports in an online post that the company urged the court to
Devices
FDA has published a guidance, Submission and Review of Sterility Information in Premarket Notification (510(k)) Submissions for Devices Labeled as Sterile, to update and clarify the information regarding sterilization processes that FDA recommends that sponsors include in 510(k)s for devices labeled as sterile. The document says it
Devices
Medical device cybersecurity vulnerabilities are going to continue to evolve and emerge, and premarket controls are simply not sufficient to manage the threat throughout a device’s lifespan, CDRH associate director for science and strategic partnerships Suzanne Schwartz told a public workshop 1/20 in Silver spring, MD while announcing
Drugs
The House Committee on Oversight and Government Reform has planned a 1/26 hearing on “Developments in the Prescription Drug Market: Oversight.” The committee has reportedly asked former Turing Pharmaceuticals head Martin Shkreli to testify, along with Valeant Pharmaceutical's interim CEO Howard Schiller. Rising drug prices have caught
Devices
CDRH has posted a guidance on “Implanted Blood Access Devices for Hemodialysis” that provides recommendations for complying with special controls issued as part of a Center device reclassification from Class 3 to Class 2. The devices are intended to provide access to a patient’s blood for hemodialysis. The document
Drugs
Perrigo has begun a recall of its over-the-counter Children’s Guaifenesin Grape Liquid and Guaifenesin DM Cherry Liquid due to a potential defect with the dosage cup. A recall notice says some packages contain an oral dosing cup with incorrect dose markings. It notes that use of these
Drugs
The AIDS Healthcare Foundation (AHF) is asking FDA to take enforcement action against Gilead Sciences for off-label promotion of its Truvada (emtricitabine and tenofovir disoproxil fumarate) for situational pre-exposure prophylaxis (PrEP) to prevent HIV infection. A recent letter to FDA acting commissioner Stephen Ostroff is the latest AHF
Drugs
Senate Health, Education, Labor and Pensions (HELP) Committee chair Lamar Alexander (R-TN) says his committee will proceed with a “step-by-step” approach to move forward several bills on biomedical innovation. The approach is the Senate’s version of the 21st Century Cures Act that the House passed in
Devices
Biorex Labs is petitioning FDA to exempt devices classified as “Method, Metallic Reduction, Glucose (Urinary, Non Quantitative) in a reagent tablet format from the 510(k) premarket notification requirement. The company’s request says that the device is intended to non-quantitatively or semiquantitatively detect/measure reducing sugars such as
Drugs
The Generic Pharmaceutical Association (GPhA) says that one of the most important outcomes of a successful Biosimilar User Fee Act (BsUFA) reauthorization agreement would be “to align on a biosimilar review process that facilitates approval of biosimilar products developed in an efficient manner that capitalizes on the novel development pathway
Drugs
CDER Office of Hematology and Oncology Products (OHOP) director Richard Pazdur says that in 2015 OHOP approved 16 new molecular entities including drug approvals for non-small cell lung cancer, colorectal cancer, breast cancer, melanoma, renal cancer, and pancreatic cancer. Writing in an agency online From Our Perspective post, Pazdur
Drugs
Stakeholders contacted by Bloomberg BNA Pharmaceutical Law & Industry Report have given their predictions about FDA actions likely to occur in a number of important areas in 2016. Key concerns for biotech companies are cited as reauthorization of drug user fee programs, implementation of the biosimilar drug pathway, drug compounding,
Devices
FDA has sent a Warning Letter to dental device maker DiamoDent (Anaheim, CA) after an inspection last year cited the firm over quality system regulation deviations. The firm makes Class dental prosthetic permanent and temporary implants and abutments. Among the citations in the letter are: 1. Failure to confirm that
Devices
FDA has cleared an Advanced Cooling Therapy 510(k) for the Esophageal Cooling Device for modulating and controlling patient temperature when clinically indicated through a single use, fully-enclosed triple lumen system that is inserted into the esophagus. “Two lumens attach to existing temperature modulation equipment while a third lumen
Drugs
The U.S. Supreme Court has rejected an appeal from Johnson & Johnson over a $63 million judgment awarded to a family whose daughter developed toxic epidermal necrolysis (TEN) after being given multiple doses of Children’s Motrin. The parents argued that the company should have acted unilaterally to change
FDA Policy/General
Federal Register Notice: FDA’s Center for Tobacco Products is opening a docket to obtain data and information related to psychosocial predictors of uptake and continued use of tobacco products, including specific categories of tobacco products and specific individual tobacco products, as well as other products from which predictors may
FDA Policy/General
Federal Register Notice: FDA is requesting any industry organizations interested in participating in the selection of voting industry representatives to serve on CDRH’s Technical Electronic Product Radiation Safety Standards Committee notify the agency in writing. It is also requesting nominations for voting industry representatives to serve on the committee.
Drugs
FDA investigators found multiple violations of current good manufacturing practice (CGMP) regulations for finished pharmaceuticals in a 7/6-7/8/15 inspection at Chan Yat Hing Medicine Factory, Kowloon, Hong Kong, according to a just-released 12/15/15 Warning Letter. The letter says the firm did not respond