Drugs
Fresenius Kabi has recalled a single lot of dexmedetomidine HCl 0.9% sodium chloride injection, 200 mcg/50 mL (4 mcg /mL) in a 50 mL vial due to a trace amount of lidocaine present in the lot. To date, no adverse drug experience reports have been received for the
Drugs
FDA has published a draft guidance, Cross Labeling Oncology Drugs in Combination Regimens, with the agency’s current recommendations about including relevant information in the labeling for oncology drugs approved for use in a combination regimen, including important consideration for cross labeling of the drugs. The document says it does
Drugs
The Stericycle Recall Insights report for the third quarter of 2020 shows that drug recalls increased markedly in the quarter while medical device recalls fell to their lowest level in several quarters. The report says that drug recall activity increased by 49.5% in the third quarter, with affected units
Drugs
FDA has published a draft guidance, Biosimilarity and Interchangeability: Additional Draft Q&As on Biosimilar Development and the BPCI Act, with answers to common questions from prospective applicants and other interested parties regarding the Biologics Price Competition and Innovation Act (BPCIA) of 2009. The document says the question-and-
Drugs
FDA has accepted for review an Alvotech USA BLA for its AVT02, a proposed biosimilar to the reference product AbbVie’s Humira (adalimumab) with high concentration dosage forms. A company statement says AVT02 is one of five product candidates from Alvotech that will be commercialized in the U.S. by
FDA Policy/General
Federal Register notice: FDA makes available 30 additional draft and revised draft product-specific guidances on the design of bioequivalence studies to support ANDAs. To view the notice, click here.
FDA Policy/General
Federal Register notice: FDA has issued an order permanently debarring Richard M. Simon from providing services in any capacity to a person that has an approved or pending drug product application. In January, Simon was convicted on one count of racketeering conspiracy related to his role as regional sales manager
FDA Policy/General
The CDER Office of Prescription Drug Promotion (OPDP) has updated its core launch review process as explained in new frequently asked questions. OPDP says it has been evaluating trends in core launch material submissions such as sales and visual aids, patient brochures, and professional journal and magazine ads from sponsors
Biologics
FDA has posted a page to give vaccine product manufacturers information about electronically submitting postmarket individual case safety reports to the Vaccine Adverse Events Reporting System (VAERS). The notice says CBER has implemented the International Council on Harmonization’s Individual Case Study Report specification to support electronic reporting of vaccine
Devices
FDA has approved Armis Biopharma’s VeriFixx Small Bone Implant for the fixation of osteotomies and reconstruction of the lesser toes following correction procedures for hammertoe, claw toe and mallet toe. The company says the device is designed to make such surgical corrections more accessible to patients through shorter time
Biologics
The CBER Office of Compliance and Biologics Quality says its review of a Web site maintained by the Regenerative Cell Institute, Las Vegas, NV, indicates the firm markets cellular products derived from either human adipose tissue or umbilical cord to consumers to treat various diseases or conditions. An 11/10
Devices
FDA has cleared an Andersen Sterilizer 510(k) for its EOGas 4 Ethylene Oxide Gas Sterilizer and associated accessories for sterilizing duodenoscopes and colonoscopes. The device is labeled for sterilizing reusable medical devices that are sensitive to moisture, heat, corrosion or radiation, the company says. It was originally cleared in
Drugs
FDA has approved a Lantheus Holdings and Progenics Pharmaceuticals supplemental NDA for Definity Room Temperature (perflutren lipid microsphere) injectable suspension, an ultrasound enhancing agent intended for use to enhance suboptimal echocardiograms. Its modified formulation allows both storage and shipment at room temperature (Definity’s previously approved formulation requires refrigerated storage)
Drugs
FDA has informed Bristol-Myers Squibb that it will not complete its review of the company’s BLA for lisocabtagene maraleucel (liso-cel) by the 11/16 PDUFA action date. The drug is indicated for treating adults with relapsed or refractory large B-cell lymphoma after at least two prior
Drugs
FDA has granted Lucira Health an Emergency Use Authorization for the first prescription molecular diagnostic test for Covid-19 that can be performed entirely at home. The Covid-19 All-In-One Test Kit can produce a positive or negative result at home within 30 minutes. The authorization was based
Drugs
Pfizer and BioNTech say they are planning to submit within days an Emergency Use Authorization request for their Covid-19 vaccine candidate BNT162b2 after a final analysis showed a vaccine efficacy rate of 95%, which was a significant improvement from the 90% reported in a preliminary analysis last week (see
FDA Policy/General
Federal Register notice: FDA is seeking comments on an information collection extension entitled “Expedited Programs for Serious Conditions — Drugs and Biologics” (OMB Control Number 0910-0765). The collection supports agency procedures designed to expedite the development, evaluation, and marketing of new therapies intended to treat persons with life-threatening and
FDA Policy/General
Federal Register notice: FDA has submitted to OMB an information collection revision entitled “Registration of Human Drug Compounding Outsourcing Facilities Under Section 503B of the Federal Food, Drug, and Cosmetic Act and Associated Fees” (OMB Control Number 0910–0776). The collection supports FDA’s policy allowing drug products compounded in
Drugs
The HHS Office of Inspector General (OIG) says it has significant concerns about companies offering or paying remuneration, and healthcare professionals (HCP) soliciting or receiving remuneration, in connection with speaker programs. “Based on our investigations and enforcement actions,” an OIG fraud alert says, “this remuneration is often offered or paid
FDA Policy/General
Federal Register notice: FDA is correcting a notice that appeared in the 1/8 Federal Register announcing the approval withdrawals for 19 NDAs from multiple applicants. That notice indicated that FDA was withdrawing R2 Pharma’s NDA 202342, esomeprazole strontium delayed-release capsules. Because of clerical errors in the agency’
Devices
Sens. Charles Grassley (R-IA) and Elizabeth Warren (D-MA) have asked FDA to issue its proposed rule on over-the-counter hearing aids as quickly as possible. In an 11/13 letter, the senators say that since President Donald Trump signed the Over-the-Counter Hearing Aid Act into
Drugs
An 11/13 petition filed by Epstein Becker Green on behalf of an unnamed client asks FDA to require that adequate cardiovascular safety and all-cause mortality data be submitted to the agency for review before approving roxadustat for treating anemia in patients with chronic kidney disease. The petition also