Devices
To improve FDA’s emergency use authorization (EUA) for Covid-19 serology (antibody) tests, the agency says it is working on EUA templates that laboratories and commercial manufacturers may use to facilitate the preparation and submission of such requests. The serology tests will likely play a huge role in identifying
Drugs
Avet Pharmaceuticals has recalled several lots of tetracycline HCl capsules, 250 mg and 500 mg, 100-count bottles due to low out-of-specification dissolution test results. Low dissolution results in less tetracycline available in the body to fight infection, which can lead to treatment failures, a recall notice says.
Drugs
FDA has sent Nova Botanix a Warning Letter after reviewing the company’s Web site and determining that its CBD products were being marketed for unapproved drug uses in treating or preventing Covid-19. The Web site included claims like “Five ways CBD can Boost Your Immune System during the
Drugs
FDA has approved an Incyte Corp. NDA for Pemazyre (pemigatinib) for treating adults with certain types of previously treated, advanced cholangiocarcinoma, a rare cancer that forms in bile ducts. “At diagnosis, a majority of patients with cholangiocarcinoma have advanced disease, meaning that the disease is no longer treatable with surgery,
Drugs
Fresenius Kabi has recalled 13 lots of ketorolac tromethamine injection, 30 mg/ml, and ketorolac tromethamine injection 60 mg/2 ml due to the presence of particulate matter, which was identified as carbon, silicon, oxygen and polyamides. Particulate matter was found in eight reserve sample vials, a recall notice says.
FDA Policy/General
Perrigo Company has completed the previously announced acquisition of a portfolio of generic dosage forms and strengths of Retin-A (tretinoin) from Matawan Pharmaceuticals. Perrigo was the authorized generic distributor of these products from 2005-2013. Janssen Pharmaceuticals has suspended dosing in two Phase 2 clinical trials of their FAAH
Drugs
International Laboratories has recalled one lot (Lot# 117099A) of clopidogrel tablets 75 mg due to a mislabeling. The product may contain clopidogrel 75mg or simvastatin Tablets 10 mg, according to a recall notice. Missed doses of clopidogrel increases the risk of heart attack and stroke, while unintentional ingestion of simvastatin,
Drugs
CDER has revised a Manual of Policies and Procedures (MAPP 5700.1, Rev.1) entitled “ANDA Amendments and Supplements Reviewed by the Division of Filing Review.” The document outlines policies and procedures for the Center to determine whether an amendment or supplement should be reviewed by OGD’s Division of
Drugs
FDA has added content to a question-and-answer appendix for its guidance on “Conduct of Clinical Trials of Medical Products during Covid-19 Public Health Emergency.” The amended appendix includes new discussions on conducting remote clinician-reported outcome or performance outcome assessments; remote site monitoring; electronic common technical document
Drugs
FDA has granted Hutchison China MediTech two fast track designations for surufatinib for treating both advanced and progressive pancreatic neuroendocrine tumors (NET) and non-pancreatic NET in patients who are not amenable for surgery. The company describes surufatinib as a novel, oral angio-immuno kinase inhibitor that “selectively inhibits the
Drugs
NIH, FDA, CDC and the European Medicines Agency are looking to develop an international strategy for a coordinated research response to the Covid-19 pandemic. The planned “Accelerating Covid-19 Therapeutic Interventions and Vaccines (ACTIV)” partnership will develop a collaborative framework for prioritizing vaccine and drug candidates, streamlining clinical trials,
Drugs
FDA has approved a Seattle Genetics NDA for Tukysa (tucatinib) for use in combination with chemotherapy (trastuzumab and capecitabine) for treating adult patients with advanced forms of HER2-positive breast cancer that can’t be removed with surgery, or has spread to other parts of the body, including the brain,
Drugs
A southern Florida federal judge has entered an emergency temporary restraining order and a preliminary injunction against Genesis II Church of Health and Healing (Genesis) and four individuals, requiring them to immediately stop distributing “Miracle Mineral Solution” (MMS), an unapproved and potentially harmful treatment offered for sale to treat coronavirus
Drugs
Harvard Medical School researchers say the current search for treatments for Covid-19 “represent fundamental threats to the U.S. drug development process.” Writing in the New England Journal of Medicine, the researchers say it is a false dichotomy to suggest it is necessary to choose between rapid deployment of
Drugs
FDA has issued an immediately-in-effect guidance describing its intention to exercise enforcement discretion regarding outsourcing facilities compounding some drugs on the agency drug shortage list for use by hospitalized patients. The document says that while the agency generally tries to address potential and actual drug shortages by working
Biologics
FDA commissioner Stephen Hahn says individuals who have recovered from Covid-19 could help others by donating blood plasma to be used to manufacture hyperimmune globulin that can treat other Covid-19 patients. In a statement, Hahn says that people who have fully recovered from Covid-19 for at least
Devices
FDA has postponed a 5/5-planned public meeting entitled “Medical Device User Fee Amendments for Fiscal Years 2023 Through 2027.” The meeting, which was set to take place by Webcast only, will now be rescheduled at a later date. The meeting was scheduled to discuss proposed recommendations for reauthorizing
Drugs
FDA commissioner Stephen Hahn says that to date the agency staff has been performing user fee review activities despite also being heavily involved in Covid-19-related activities. In a statement, Hahn says that part of the review activities has involved looking at ways to use technology and established agreements
FDA Policy/General
The Center for Veterinary Medicine (CVM) has sent Warning Letters to two companies it says are distributing unapproved chloroquine phosphate products. The letters went to Fishman Chemical of North Carolina, Vero Beach, FL, and Dr. G’s Marine Aquaculture, Pembroke Pines, FL. In both instances, CVM says its review of
Drugs
Mayne Pharma has filed an NDA for E4/DRSP (estetrol and drospirenone), a combined oral contraceptive indicated for preventing pregnancy. The company describes the novel, next-generation oral contraceptive as containing estetrol (E4) 15 mg and drospirenone (DRSP) 3 mg. E4 is a naturally occurring estrogen that is produced by
Drugs
Three healthcare activists whose suit persuaded a federal judge to order companies to add 10 years’ of information to the ClinicalTrials.gov Web site say that site could help inform the public about Covid-19 drug trials if government agencies would require companies to submit all their trial results. Writing
FDA Policy/General
Federal Register notice: FDA has submitted to OMB an information collection revision entitled “Premarket Notification Procedures — 21 CFR Part 807, Subpart E” (OMB Control Number 0910–0120). The revision addresses electronic submission templates that will serve as guided submission preparation tools for industry to improve submission consistency and enhance efficiency