Drugs
FDA has issued an immediately-in-effect guidance, Policy for Testing of Alcohol (Ethanol) and Isopropyl Alcohol for Methanol, Including During the Public Health Emergency, to alert drug manufacturers and pharmacists who engage in drug compounding to the potential public health hazard of alcohol (ethyl alcohol or ethanol) or isopropyl
Drugs
FDA has made available a new guidance entitled Protecting Participants in Bioequivalence Studies for Abbreviated New Drug Applications During the Covid-19 Public Health Emergency. The document is intended to assist prospective ANDA applicants in ensuring the protection of participants when resuming or initiating bioequivalence (BE) studies conducted to support
Drugs
An FDA inspection last month at Lonza’s Viral Vector contract-manufacturing facility in Houston, TX, resulted in a four-item FDA-483, but more importantly it released an FDA review hold on a Bristol-Myers Squibb (BMS) BLA for lisocabtagene maraleucel (liso-cel), indicated for treating adults with relapsed
Drugs
FDA is alerting health care professionals about labeling updates for the preparation of vinca alkaloids, a group of chemotherapy agents that includes vincristine sulfate injection, vinblastine sulfate injection, and vinorelbine tartrate injection. To reduce the potential for unintended intrathecal (spinal) administration, which causes death or severe neurological injury, the agency
Drugs
Attorneys Sara Koblitz and Kurt Karst (Hyman, Phelps & McNamara) say the Orange Book Modernization Act signed by President Trump 1/5 primarily codifies existing FDA patent listing practices. Writing online in their firm’s FDA Law Blog, Koblitz and Karst say that although there is little new in the
Drugs
FDA has cleared a Hyperfine Research 510(k) for its deep-learning image analysis software to measure brain structure and pathology in images acquired by the Swoop Portable MR Imaging System. The analysis software relies on tools featuring automatic measurement of ventricular volume, brain extraction, brain alignment, and midline shift
Drugs
FDA has issued an immediately-in-effect guidance, Covid-19: Potency Assay Considerations for Monoclonal Antibodies and Other Therapeutic Proteins Targeting SARS-CoV-2 Infectivity, to assist sponsors in developing monoclonal antibodies and other therapeutic proteins for use as Covid-19 therapeutics. The document says that a critical quality control
Drugs
PDUFA reauthorization discussions were held by various committees, working groups, and subgroups in five sessions held virtually in October and November 20. Meeting summaries and minutes for each session were released by FDA and show: * FDA/Industry Postmarket Subgroup, 10/28/20 — continued discussions of possible options of common interest
Drugs
FDA has granted Timber Pharmaceuticals an orphan drug designation for TMB-003, the company’s locally delivered formulation of sitaxsentan, indicated for treating systemic sclerosis. The condition can be disfiguring and may cover joints and cause pain that affects movement and mobility, the company says. It describes sitaxsentan as a
Drugs
FDA has told Marinus Pharmaceuticals that the efficacy and safety data resulting from the company’s Phase 3 Marigold Study using oral ganaxolone in children and adults with CDKL5 deficiency disorder appear sufficient to support the filing of an NDA. The company says that the adequacy of the data to
Drugs
FDA has granted Leading BioSciences a fast track designation for LB1148 for treating postoperative gastrointestinal (GI) dysfunction associated with pediatric heart surgery. The designation was based on the therapy’s potential to accelerate return of bowel function and reduce the risk of serious and life-threatening complications associated with corrective
Drugs
In a 6-3 split on ideological lines, the Supreme Court has granted an FDA request to reinstate a federal requirement that women being prescribed mifepristone for a medical abortion in the early stages of pregnancy have to obtain the pill in person from a healthcare provider and sign a
Drugs
A Florida federal court has ruled that state labeling and design defect claims in a multidistrict suit against the makers, repackagers, retailers, and distributors of generic forms of Sanofi’s Zantac are preempted by federal law. Attorney Kaitlyn Stone (Faegre Drinker) says the court dismissed claims against 32 generic manufacturers
Drugs
FDA has granted Harpoon Therapeutics an orphan drug designation for HPN217 for treating multiple myeloma. The tri-specific T cell activating recombinant protein construct targets B-cell maturation antigen, which is expressed on malignant multiple myeloma cells, the company says. Last April, Harpoon announced dosing of the first patient with
Drugs
FDA has accepted for priority review a Bayer NDA for finerenone, an investigational drug for patients with chronic kidney disease (CKD) and Type 2 diabetes. The submission was based on data from the Phase 3 FIDELIO-DKD trial, which were published in the 10/23/2020 New England Journal of
Drugs
FDA commissioner Stephen Hahn and principal deputy commissioner Amy Abernathy say the nation still has a limited understanding of the safety profile of cannabidiol (CBD) and many other cannabis-derived compounds, including potential safety risks for people and animals. “At FDA we see these knowledge gaps as an opportunity to
Drugs
A 1/7 petition submitted on behalf of Pharmaceutical Research and Manufacturers of America, the Partnership for Safe Medicines, and the Council for Affordable Health Coverage asks FDA not to authorize the state of Florida’s drug importation program proposal and to disclose the identities of foreign sellers for public
Drugs
FDA and the Duke-Margolis Center for Health Policy will hold a two-day virtual workshop focused on considerations about observational study design and conduct when using evidence from such studies to inform regulatory decisions. A workshop announcement says the 2/16-17 event will highlight preliminary results from ongoing
Drugs
FDA commissioner Stephen Hahn has been asked to provide a progress report on recent steps the agency has taken to combat the opioid crisis. A 1/11 letter to Hahn from 48 state attorneys general requests an update on efforts to reduce prescription opioid abuse and accidental deaths using new
Drugs
FDA chief counsel Stacy Cline Amin is stepping down effective today after leading the agency’s legal shop for over two years. “During a time of unprecedented challenges at the FDA, Stacy has played a critical role in nearly every aspect of our Covid-19 pandemic response efforts, including record
Drugs
Fresenius Kabi USA has recalled one lot of ketorolac tromethamine injection, 30 mg/mL, 1 mL fill in a 2 mL amber vial, due to the presence of particulate matter detected in reserve sample vials. No adverse event reports have been reported with the recalled lot, according to a recall
Drugs
The U.S. Food and Drug Administration (FDA) has accepted a Boehringer Ingelheim and Eli Lilly supplemental NDA for Jardiance (empagliflozin) for reducing the risk of cardiovascular death and hospitalization for heart failure and slowing kidney function decline in adults with chronic heart failure with reduced ejection fraction, including those