Devices
FDA has cleared a Safe Medical Design 510(k) for the Signal Catheter, a urinary catheter that is designed to reduce urethral trauma caused by premature balloon inflation during placement. The company says that there are 30 million urethral catheters annually used in the U.S., with up to 500,
FDA Policy/General
Federal Register notice: FDA has submitted to OMB an information collection extension for “Financial Disclosure by Clinical Investigators” (OMB Control Number 0910-0396). To view the notice, click here.
FDA Policy/General
Comments Sought on Cannabis Scheduling Recommendations Federal Register notice: FDA seeks comments on World Health Organization recommendations to impose international manufacturing and distributing restrictions on certain cannabis drug substances. 03/01/2019 Comments Sought on Fentanyl Scheduling Recommendations Federal Register notice: FDA is seeking comments on World Health Organization drug
FDA Policy/General
DEVICES FDA has approved a TransMedics PMA for the Organ Care System Lung platform for use in standard double lung transplants. Approval was based on data from the INSPIRE Trial, the first and largest controlled clinical organ preservation trial in lung transplantation that was conducted at 21 leading international academic
Drugs
FDA has issued a final guidance on Evaluation of Bulk Drug Substances Nominated for Use in Compounding Under Section 503B of the Federal Food, Drug, and Cosmetic Act. The document addresses the agency’s policies for developing a list of bulk drug substances that can be used in compounding. It
FDA Policy/General
Federal Register notice: FDA is seeking comments on World Health Organization recommendations to impose international manufacturing and distributing restrictions, under international treaties, on certain drug substances. The international drug scheduling recommendations apply to: Dronabinol (delta-9-tetrahydrocannabinol) and its stereoisomers; cannabis, cannabis resin, extracts and tinctures; cannabidiol preparations; and pharmaceutical
Drugs
The FTC has reached a settlement in FTC v. Actavis, a 2009 case alleging that Solvay and three generic drug companies illegally agreed to restrict generic competition to Solvay’s branded testosterone-replacement drug AndroGel for nine years. The settlement covers those products that Solvay may have been marketing or
FDA Policy/General
Federal Register notice: FDA is seeking comments on World Health Organization drug scheduling recommendations on certain narcotic drugs. The international drug scheduling recommendations apply to: Cyclopropyl fentanyl; methoxyacetyl fentanyl; ortho-fluorofentanyl; para-fluorobutyrfentanyl; n-ethylnorpentylone; and four additional substances. To view the notice, click here.
Drugs
AurobindoPharma has expanded a 12/2018 recall to include 38 lots of valsartan and amlodipine and valsartan tablets after detecting trace amounts of a human carcinogen in the finished drug product. The impurity detected is N-nitrosodiethylamine, which is a substance that occurs naturally in certain foods, drinking water, air
Drugs
FDA has issued a Warning Letter to CanaRx for causing the distribution of unapproved new drugs and misbranded drugs to U.S. consumers. The letter outlines the company’s “scheme” to contract with public and private entities to provide prescription drug coverage to their employees. “In the scheme, CanaRx facilitates
Drugs
Pulse Biosciences has submitted a 510(k) for the CellFX System for use in common dermatologic procedures to remove general benign lesions including sebaceous hyperplasia, a common but difficult to treat facial lesion and seborrheic keratosis, the most common benign raised pigmented lesion. The device uses “non-thermal delivery of
Drugs
FDA has approved an Adlon Therapeutics 505(b)(2) NDA for Adhansia XR (methylphenidate hydrochloride) extended-release capsules for treating attention-deficit/hyperactivity disorder in patients six years and older. In a simulated adult workplace environment study, Adhansia XR demonstrated statistically significant improvement over placebo at 1, 2, 5, 8,
Biologics
FDA officials say the agency lacks the resources needed to pursue a comprehensive crackdown on the growing private stem cell industry. Responding to a lengthy Washington Post investigative report reviewing cases of several people who have been hospitalized after being injected with products made from umbilical cord blood, FDA commissioner
Devices
FDA has issued a safety alert on using robotically-assisted surgical devices in women’s health procedures, including mastectomy and other cancer-related surgeries. The alert says that the safety and effectiveness of these devices in such cases has not been established. “There is limited, preliminary evidence that the use
Drugs
FDA has approved a Janssen Pharmaceutical supplemental BLA for Tremfya (guselkumab) One-Press, a single-dose, patient-controlled injector for adults with moderate-to-severe plaque psoriasis. The company says One-Press offers a controlled injection that hides the needle throughout the process. Approval was based on results from the
Drugs
FDA says it has concluded that the scope of exclusivity ordered by a federal court for Eagle’s leukemia drug Bendeka extends to all applications containing the same active moiety as Bendeka, bendamustine, and bars approval of any application containing bendamustine for any exclusivity-protected indication starting on the 12/
Drugs
The CDER Office of Pharmaceutical Quality (OPQ) says that in 2018 it worked on implementing four strategic priorities: collaboration, innovation, communication, and engagement. The OPQ 2018 annual report says it improved integration of internal processes to find more efficiencies. It also held public events to encourage quality-related innovation within
Drugs
On the heels of a substantial budget boost (see story) for this fiscal year, FDA commissioner Scott Gottlieb has outlined for U.S. House of Representative appropriators significant modernization efforts underway in CDER’s Office of New Drugs (OND). Beginning in the next few months, CDER will adopt new standard
Drugs
Parexel International has hired former FDA Oncology Center of Excellence deputy director Amy McKee as regulatory consulting services vice president. McKee, who spent 11 years at FDA, will focus on building Parexel’s new cross-functional oncology initiative, according to the company. At FDA, she served as Office of Hematology
Drugs
FDA has approved Genentech’s Herceptin Hylecta (trastuzumab and hyaluronidase-oysk) subcutaneous injection for treating patients with HER2-positive early breast cancer (node-positive, or node-negative and ER/PR-negative or with one high-risk feature) in combination with chemotherapy and HER2-positive metastatic breast cancer in combination with
FDA Policy/General
Federal Register notice: FDA has announced a public meeting and an opportunity for public comment on “Patient Perspectives on the Impact of Rare Diseases: Bridging the Commonalities.” The meeting is intended to obtain patients’ and caregivers’ perspectives on impacts of rare diseases on daily life and to assess commonalities that
FDA Policy/General
Federal Register notice: FDA is amending its regulations to reflect a change of address for CDER’s Office of Generic Drugs Document Room from Rockville, MD, to Beltsville, MD. The new address is: Central Document Room, Center for Drug Evaluation and Research, Food and Drug Administration, 5901–B Ammendale Rd.