FDA Policy/General
DEVICES Bovie Medical has received 510(k) clearance from FDA for six new hand piece configurations that expand its J-Plasma pistol grip surgical device. The pistol grip hand piece will now be available with instrument lengths of 15cm, 33cm and 45cm, in addition to the existing length of 27cm.
Drugs
FDA has released the Establishment Inspection Report (EIR) associated with a complete response letter issued to Revance Therapeutics on its BLA for daxibotulinumtoxinA for injection and its use in treating moderate to severe glabellar (frown) lines. The EIR recommended that the agency withhold approval of the BLA due to the
Devices
FDA has issued two final orders reclassifying certain Hepatitis C virus (HCV) diagnostic tests from Class 3 to Class 2, which will allow the tests to use the agency’s 510(k) pathway rather than the PMA process. The two types of HCV diagnostic tests being reclassified are nucleic acid-
FDA Policy/General
Federal Register: FDA is seeking comments on an information collection extension entitled “Administrative Detention and Banned Medical Devices” (OMB Control Number 0910-0114). The collection covers FDA’s authority to detain during inspections devices that are believed to be adulterated or misbranded. To view the notice, click here.
FDA Policy/General
Federal Register notice: FDA has corrected a 10/27 notice identifying the Web site where to find CDRH’s fiscal year 2022 proposed guidance development. The document contains the date 11/26 and it should read 12/27. To view the notice, click here.
Drugs
FDA 11/19 amended the emergency use authorizations (EUA) for both the Moderna and Pfizer-BioNTech Covid-19 vaccines to allow a booster dose for all individuals 18 years of age and older. Prior to this action, booster shots were authorized for individuals 65 years of age and older, individuals
Devices
CDRH says a recent article published in the Journal of Clinical Pharmacy and Therapeutics entitled Assessing Dosing Errors in Legacy and Low Dose Tip ENFit Syringes sheds some light on an agency safety alert about the risk of medication overdose from the moat area of ENFit LDT syringes. Last month,
FDA Policy/General
The Covid-19 emergency has been the single greatest catalyst for advancing the use of real-world evidence (RWE) at FDA, according to former FDA chief counsel and now Morrison & Foerster partner Stacy Cline Amin. Writing in a 11/19 Clinical Leader guest column, Amin noted that in the
Biologics
FDA has granted BioMarin accelerated approval for Voxzogo (vosoritide) for injection, indicated to increase linear growth in pediatric patients with achondroplasia, the most common form of disproportionate short stature, in those five years of age and older with open epiphyses (growth plates). The approval was based on data showing an
FDA Policy/General
Federal Register notice: FDA has determined the regulatory review period for patent extension purposes for Jazz Pharmaceuticals’ Sunosi (solriamfetol Hcl), indicated to improve wakefulness in adult patients with excessive daytime sleepiness associated with narcolepsy or obstructive sleep apnea. The review period is 8,209 days, which includes 7,664 days
FDA Policy/General
Federal Register notice: FDA is seeking comments on an information collection extension entitled “Generic Drug User Fee Program” (OMB Control Number 0910-0727). It was revised to include the current user fee agreement. To view the notice, click here.
Drugs
Heron Therapeutics says it has submitted an NDA for its HTX-019 (aprepitant) injectable emulsion indicated for preventing postoperative nausea and vomiting (PONV) in adults. A company statement says HTX-019 is a proprietary intravenous formulation of aprepitant that is approved for PONV prevention. The injectable emulsion formulation intended for
Devices
FDA has cleared a Lunit 510(k) for its Insight MMG, an artificial intelligence (AI) application for breast cancer detection. The AI software for breast cancer joins the the company’s AI solutions for chest x-ray and mammography. Insight MMG is a radiology product which analyzes mammography images with
Devices
FDA is reminding healthcare providers about the risk of major complications if cardiac perforation occurs during leadless pacemaker implantation. An agency letter to providers says the overall risk of cardiac perforation associated with leadless pacemaker implantation appears similar to the risk associated with traditional transvenous pacing systems. “However,” the letter
Drugs
FDA has approved a new indication for Merck’s Keytruda for adjuvant treatment of patients with renal cell carcinoma at intermediate-high or high risk of recurrence following nephrectomy or following nephrectomy and resection of metastatic lesions. The company says the approval is based on data from the pivotal Phase
Drugs
FDA says its pharmacists are available to help consumers achieve the best possible outcome when taking drugs. An online post says agency pharmacists are available by telephone or e-mail to answer a variety of questions. “Call your local pharmacist or FDA’s drug information pharmacists if you have questions
Drugs
FDA says that since drug manufacturers should have completed a nitrosamine impurity risk assessment based on the timetable in a 2/2021 guidance, it is giving companies additional points to consider in developing their nitrosamine mitigation strategies that are due 10/1/2023. An online update says the agency has
Biologics
FDA has told a Texas federal court that it will need 55 years to respond to a Freedom of Information Act (FOIA) request from Public Health and Medical Professionals for Transparency (PHMPT) looking for data and information on the Pfizer/BioNTech Covid-19 vaccine. The conservative Blaze News Website says
Drugs
FDA has approved the resumption of enrollment in an AB Science Phase 3 confirmatory study of masitinib in patients with amyotrophic lateral sclerosis (ALS). A company announcement says the study is actively enrolling in 15 countries in Europe, the U.S., and other regions. The study has three parallel groups
Devices
FDA has qualified the MED Institute’s medical device development tool (MDDT) for virtual MRI safety evaluations to determine if MRI imaging is safe for patients with implanted medical devices. The institute says its MDDT uses computational modeling and simulation to predict RF-induced heating of passive medical devices during
Devices
FDA has cleared a MIM Software 510(k) for its MIM SurePlan MRT, a software package for molecular radiotherapy. The software features artificial intelligence segmentation models, which simplify the contouring process for dosimetry, the company says, adding that it provides quicker and enhanced results compared to manual and atlas-based
FDA Policy/General
Federal Register notice: FDA is withdrawing approval of 18 ANDAs from multiple applicants after they notified the agency that the drugs were no longer marketed. To view the notice, click here.