Drugs
Qmart (Elmwood Park, NJ) has recalled all lots of its Imperial Gold 2000, PremierZen Extreme 3000, Burro en Primavera 60000 and Imperial Platinum 2000 after an FDA analysis found the products to be tainted with undeclared sildenafil and/or tadalafil, which are ingredients known as phosphodiesterase (PDE-5) inhibitors found
Drugs
The FDA Cardiovascular and Renal Drug Advisory Committee will consider a FibroGen NDA for roxadustat to treat anemia of chronic kidney disease in both dialysis-dependent and non-dialysis-dependent patients on 7/15. The company says its NDA is supported by positive results from a global Phase 3 program
Drugs
The CBER Office of Compliance and Biologics Quality says its review of a Web site maintained by Curex, Inc., New York, NY, determined that the firm markets mixtures of allergenic extracts intended for sublingual immunotherapy. A 3/23 Notice of Violation says the Web site refers to the products as
Drugs
FDA says its review of listing information provided by RPK Pharmaceuticals, Union City, CA, for its clotrimazole and betamethasone dipropionate cream determined that the firm submitted a label for the drug that does not match the name of the listed drug. A 3/26 Warning Letter says the agency previously
Devices
The 9th Circuit Court of Appeals has affirmed in part and reversed in part a California federal court’s decision dismissing a whistleblower’s False Claims Act suit alleging that Medtronic fraudulently obtained FDA clearance for several medical devices used in spinal fusion surgeries, unlawfully marketed the devices for off-
FDA Policy/General
It’s been two and a half months since the inauguration and the Biden Administration does not appear to be in any rush to nominate an FDA commissioner, which could leave current acting commissioner Janet Woodcock at the helm for almost the remainder of the year, if the administration so
Drugs
FDA has released the FDA-483 issued following a 12/1/20-1/28/21 agency inspection at Wells Pharmacy, a Dyersburg, TN, outsourcing facility. The inspection’s seven observations were: * failing to thoroughly review the failure of a batch or any of its components to meet any of its
Drugs
Two Troutman Pepper attorneys cite four FDA March Warning Letters to companies selling CBD products as evidence that the agency is taking a strong stance on product labeling and marketing efforts involving health claims about CBD. Their online post also says that two of the four letters cited companies for
FDA Policy/General
Former FDA lawyer Sonia Wadhwa Nath has joined Cooley as a partner in the law firm’s business litigation and healthcare regulatory practice groups based in Washington, DC. A near 12-year agency veteran, she previously served as senior counsel in the Office of the Chief Counsel, handling enforcement cases
FDA Policy/General
FDA has issued a Warning Letter to Natural Adventure (Miramar, FL) after reviewing its Web site (www.mynaturaladventure.com) and social media sites and determining its hand sanitizers are unapproved new drugs. In the letter, FDA objected to numerous claims the company made regarding its products. For example, one claim
Drugs
FDA says A-S Medication Solutions announced 4/2 a recall of acetaminophen extra strength 500 mg tablets in 100 count bottles contained in health essentials kits distributed by Humana because they contain an incomplete prescription drug label rather than the required OTC drug facts label. An agency statement says
Drugs
Public Citizen has called on HHS secretary Xavier Becerra to have the department Office of Inspector General (OIG) immediately investigate the “unprecedented and inappropriate close collaboration between FDA and Biogen regarding the company’s application for approval of the Alzheimer’s disease drug aducanumab.” In a 4/1 letter, the
Drugs
Novartis says an FDA draft guidance, Human Gene Therapy for Neurodegenerative Diseases, should leverage past learnings from small molecule, biologic, and current gene therapy experiences to develop a platform approach to support regulatory decision-making. The company comment letter says well-characterized common attributes shared across programs can facilitate the
Devices
FDA has approved a NuVasive PMA for its Simplify Cervical Artificial Disc for two-level total disc replacement. Approval was based on data that demonstrated clinical superiority at 24 months compared to anterior cervical discectomy and fusion (ACDF) in a two-level IDE study, the company says. In the study,
Drugs
Writing in a Washington Legal Foundation Legal Opinion Letter, three Sidley Austin attorneys say a recent 4th Circuit Court of Appeals decision in a case involving Boehringer Ingelheim’s blood thinner Pradaxa clarified the need to ensure that a conclusion about a drug’s risks has been reached by a
Drugs
FDA has approved a Supernus Pharmaceuticals NDA for Qelbree (viloxazine extended-release capsules) for treating attention-deficit hyperactivity disorder (ADHD) in pediatric patients 6 to 17 years of age. Qelbree is not a controlled substance, the company says. In 12/2020, Supernus announced positive results from a Phase 3 trial
Drugs
CDER has released a final guidance entitled Development of Abbreviated New Drug Applications During the Covid-19 Pandemic — Questions and Answers. The document provides general recommendations to ANDA applicants related to generic drug product development and regulatory submissions in the form of questions and answers that have been received and
Devices
FDA has cleared a Surgical Information Sciences 510(k) for an updated algorithm with new visualization capabilities for its SIS System. The device was previously cleared for visualizing brain structures such as the subthalamic nuclei (STN) in the planning and targeting images for a deep brain stimulation (DBS) procedure, and
Devices
FDA has cleared an Orthofix Medical 510(k) for its 3D-printed Construx Mini Ti Spacer System for use in enhancing anterior cervical discectomy and fusion (ACDF) procedures. ACDF procedures, which are often used to treat a herniated cervical disc or degenerative disc disease, involve replacing a patient’s damaged
Devices
The Medical Device Innovation Consortium, of which FDA is a member, has released a new report entitled Maximizing Patient Input in the Design and Development of Medical Device Clinical Trials. The report examines opportunities that exist for patient input to help define unmet need, clarify patient preferences, develop endpoints that
FDA Policy/General
Federal Register notice: FDA has announced a 5/11-12 Science Advisory Board to the National Center for Toxicological Research (NCTR) advisory committee meeting. On 5/11, the NCTR director will provide a Center-wide update on scientific initiatives and accomplishments during the past year. Each agency product center will
FDA Policy/General
Federal Register notice: FDA is seeking comments on an information collection extension entitled “Medical Device Recall Authority — 21 CFR part 810” (OMB Control Number 0910-0432). FDA regulations provide it with the authority to issue an order requiring an appropriate person, including manufacturers, importers, distributors, and retailers of a device,