Drugs
An 8/4 FDA Warning Letter notifies Amazon.com that two mole and skin tag remover products it is marketing through its Web site and distributing through Amazon fulfillment services are unapproved new drugs and are not generally recognized as safe and effective for their intended uses. The letter references
Drugs
A day after updating investors that the company had submitted additional data to FDA to support its efficacy data in a recent NDA for omaveloxolone, indicated for treating patients with Friedreich’s ataxia, Reata Pharmaceuticals now says the agency notified it that the submission’s review is being extended by
FDA Policy/General
Federal Register notice: FDA has renewed its Allergenic Products Advisory Committee for an additional two years beyond the charter expiration date. The new charter will be in effect until 7/9. To view the notice, click here.
FDA Policy/General
Federal Register notice: FDA has determined that 50 listed drug products were not withdrawn for safety or effectiveness reasons. The determination means that the agency will continue to approve ANDAs that reference the products as long as they meet relevant legal and regulatory requirements. To view the notice, click here.
Drugs
The 2nd Circuit Court of Appeals has upheld the decision of a New York federal court to grant summary judgment to FDA and Sarepta Therapeutics in a Freedom of Information Act (FOIA) case. The appeals court decision says science writer and journalism professor Charles Seife sought records from FDA relating
Devices
FDA says the 7/12 Haimen Shangbang Laboratory Equipment Co. recall of 4,165,200 viral transport media containers that were distributed in the U.S. between 10/8/21 and 2/15/22 is Class 1. An agency notice says the company recalled the products because they were distributed
Drugs
CDER regulatory counsel Heather Messick, who was lead on the European Union’s General Data Protection Regulation (GDPR) when she worked in the FDA Europe Office as an international policy analyst, says the GDPR poses several concerns for FDA. Writing in an online From a Global Perspective post, she says
Devices
A 1/29-2/15 FDA inspection at Zyno Medical, Natick, MA, found Quality System Regulation violations in the firm’s manufacturing of infusion pumps and associated administration sets. A just-released 7/12 Warning Letter says specific violations were: * failing to adequately establish and maintain procedures for implementing corrective
Devices
FDA has cleared a Bodyport 510(k) for its biomarker platform Bodyport Cardiac Scale that is intended to assess measures of heart function and fluid status for people with fluid management conditions, such as heart failure and kidney disease. “Weight monitoring is currently the noninvasive standard of care for detecting
Drugs
FDA has issued CorMedix a second complete response letter on its NDA for DefenCath (taurolidine/heparin catheter lock solution) for use in kidney failure patients receiving chronic hemodialysis through a central venous catheter. The letter said the submission cannot be approved until inspection deficiencies at the company’s contract manufacturing
Biologics
An FDA Bioresearch Monitoring Program 8/26/21-10/8/21 inspection at Valley Biosystems, West Sacramento, CA, found “objectionable conditions” in the firm’s conduct of two nonclinical Good Laboratory Practice studies. An 8/3 Warning Letter says specific violations were: * failing to ensure that each individual engaged in
Devices
A 1/29-2/15 FDA inspection at InfuTronix, Natick, MA, found Quality System Regulation and Medical Device Reporting violations in the firm’s production of infusion pumps and associated administration sets. A just-released 6/16 Warning Letter says specific violations were: * failing to analyze processes, work operations, concessions,
Biologics
FDA has issued Bavarian Nordic an emergency use authorization (EUA) for its smallpox/monkeypox vaccine Jynneos to allow healthcare providers to administer the vaccine by intradermal injection for individuals 18 years of age and older who are determined to be at high risk for monkeypox infection. The agency says allowing
FDA Policy/General
FDA and Fors Marsh Group researchers say they have examined the tradeoffs for consumer understanding of drug risks and benefits when drugs are promoted in character-space-limited (CSL) communications such as tweets. “CSL communications present a challenge for maintaining fair balance between risks and benefits in direct-to-consumer
FDA Policy/General
Federal Register notice: FDA is seeking comments on an information collection revision entitled “Q-Submissions Program for Medical Devices” (OMB Control Number 0910-0756). The document supports the agency’s guidance “Requests for Feedback and Meetings for Medical Device Submissions: The Q-Submission Program.” The revision pertains to a form
FDA Policy/General
Federal Register notice: FDA has announced a 9/22 Vaccines and Related Biological Products Advisory Committee meeting. Panel members are scheduled to discuss a BLA from Rebiotix for Rebyota (fecal microbiota, live) for reducing the recurrence of Clostridioides difficile infection in adults following antibiotic treatment. To view the notice, click
Drugs
Reata Pharmaceuticals says its May-submitted NDA for omaveloxolone, indicated for treating patients with Friedreich’s ataxia, is facing FDA scrutiny about the submission’s “strength” of efficacy evidence. The agency’s concern was expressed in a mid-cycle communication meeting, which the company says did not raise any clinical
Devices
A federal appeals court has overturned a district court decision to dismiss, due to federal preemption, product liability claims under the Connecticut Product Liability Act (CPLA) involving Bausch & Lomb’s Trulign Toric intraocular lenses. The federal appeals court ruling will now allow the product liability case to proceed. In
Drugs
FDA has granted Attralus an orphan drug designation for 124 I-AT-01 iodine (evuzamitide) as a diagnostic for managing transthyretin amyloidosis (ATTR). The company says the product utilizes its pan-amyloid binding peptide as an amyloid-specific imaging agent to detect and quantify amyloid in multiple types of systemic
Drugs
FDA has approved Myovant Sciences/Pfizer’s Myfembree (relugolix 40 mg, estradiol 1 mg, and norethindrone acetate 0.5 mg) as a one-pill, once-a-day therapy (treatment duration up to 24 months) for managing moderate to severe pain associated with endometriosis in pre-menopausal women. Previously, the drug
Drugs
A collaboration between FDA, the National Cancer Institute, patient advocacy group LUNGevity Foundation, and industry representatives has developed a forthcoming draft guidance that is intended to modernize and streamline eligibility criteria recommendations to allow more patients to easily enroll in lung cancer clinical trials. Efforts are underway to replicate the
Drugs
FDA has approved Daiichi Sankyo’s Enhertu (fam-trastuzumab-deruxtecan-nxki), an IV infusion for treating patients with unresectable or metastatic HER2-low breast cancer. “This is the first approved therapy targeted to patients with the HER2-low breast cancer subtype, which is a newly defined subset of HER2-negative