Drugs
A 2/10-2/21 FDA inspection at Kalchem International, Lindsay, OK, found significant violations of current good manufacturing practice (CGMP) regulations for finished pharmaceuticals and significant deviations from CGMP for active pharmaceutical ingredients (API). An 8/27 Warning Letter says specific issues were: * failing to have, for each batch
FDA Policy/General
Federal Register notice: FDA has announced that it issued a priority review voucher to Vertex Pharmaceutical for Trikafta (elexacaftor/tezacaftor/ivacaftor), indicated for treating patients with cystic fibrosis aged 12 years and older who have at least one F508del mutation in the cystic fibrosis transmembrane conductance regulator gene. To view
FDA Policy/General
Federal Register notice: FDA has made available a final guidance entitled Recognition and Withdrawal of Voluntary Consensus Standards; Guidance for Industry and Food and Drug Administration Staff. The document identifies the principles FDA uses for recognizing a standard, and it explains the extent of recognition and other supplementary information. To
FDA Policy/General
Federal Register notice: FDA is publishing a list of information collections that have been approved by OMB under the Paperwork Reduction Act of 1995. To view the notice, click here.
Drugs
FDA has published a draft guidance, Geriatric Information in Human Prescription Drug and Biological Product Labeling, to assist applicants in determining the appropriate placement and content of geriatric information in labeling as described in the regulations for the content and format of labeling for human prescription drug and biological products.
Drugs
A 2/17-2/20 FDA inspection at the Mayon’s Pharmaceuticals facility in Nagpur, Maharashtra, India, found significant violations of current good manufacturing practice (CGMP) regulations for finished pharmaceuticals and significant deviations from CGMP for active pharmaceutical ingredients (API). A 9/4 Warning Letter says specific violations were: * failing
FDA Policy/General
Former Microsoft CEO Bill Gates says FDA and CDC are casualties of the Donald Trump presidency that has downplayed or dismissed science and medicine in the pursuit of political gain. Interviewed by Bloomberg Television, Gates cited FDA commissioner Stephen Hahn’s rapid about-face on the benefit of convalescent plasma
Drugs
FDA has issued Mallinckrodt a complete response letter on its NDA for terlipressin and its use in treating adults with hepatorenal syndrome Type 1 (HRS-1). The letter said that, based on the available data, the agency cannot approve the NDA in its current form and it requires more information
FDA Policy/General
Federal Register notice: FDA is requesting that stakeholders notify it about their intent to participate in periodic consultation meetings on reauthorizing the Generic Drug User Fee Amendments of 2017 (GDUFA). At the end 9/2022, new legislation will be required for FDA to continue collecting user fees for subsequent fiscal
Devices
FDA has published a final guidance entitled Recognition and Withdrawal of Voluntary Consensus Standards. The document outlines principles for recognizing a standard wholly, partly, or not at all, as well as reasons and rationales for withdrawing a standard. According to the guidance, FDA: * Will publish its justification for recognition and
Devices
FDA has released an update on its ongoing pilot to develop a medical device software precertification program that notes FDA is leaning toward a “question-based approach” for its tested streamlined review which it believes will lead to a structured and consistent “ software as a medical device (SaMD)” definition in
Devices
Becton Dickinson CareFusion 303 has recalled its Alaris System Infusion Pumps due to damaged inter-unit interface connectors, loose or missing battery screws and broken upper and lower hinge posts and membrane frame. A damaged inter-unit interface connector may lead to interruption of communication or power between the PC
FDA Policy/General
Federal Register notice: FDA is correcting a 9/2 Federal Register notice that announced the availability of post-marketing pediatric-focused safety reviews of products posted between 9/2019 and 9/2020. The earlier notice was published with the incorrect product name for one of the post-marketing pediatric-focused
Drugs
FDA has released a final guidance on Assessing Covid-19-Related Symptoms in Outpatient Adult and Adolescent Subjects in Clinical Trials of Drugs and Biological Products for Covid-19 Prevention or Treatment. The document notes that sponsors may encounter challenges in identifying methods to assess the numerous and heterogeneous Covid-
Drugs
FDA has issued a temporary guidance entitled Resuming Normal Drug and Biologics Manufacturing Operations During the COVID-19 Public Health Emergency to help drug/biologic product manufacturers to “transition from operations impacted by the Covid-19 public health emergency to normal manufacturing operations.” The document provides recommendations on prioritizing products
FDA Policy/General
Federal Register notice: FDA has determined for patent extension purposes the regulatory review period for Dyax Corp.’s Takhzyro (lanadelumab-flyo), indicated for prophylaxis to prevent hereditary angioedema in patients 12 years and older. The regulatory review period was determined to be 1,857 days, which includes 1,616 days
Biologics
As Phase 3 clinical trials for Covid-19 are underway, FDA says it will soon issue a guidance for sponsors to request an Emergency Use Authorization (EUA) for their vaccines, which will also include recommendations on the data and information needed to support an EUA. A joint Web posting by
Drugs
FDA has sent Pharmacy Plus (dba Vital Care Compounder) a Warning Letter for offering unapproved drug products — Covid Pack and Covid Positive Pack — for prophylaxis, treatment and recovery from the Covid-19 virus. The letter takes issue with statements made on the company’s Web site touting the products, such
Biologics
CBER has issued an untitled letter to Laguna Beach Aesthetics, Cosmetic Dermatology and Laser Center (Laguna Beach, CA) over its unapproved cellular product derived from adipose tissue that is marketed to treat various diseases or conditions, such as cancer, chronic pain, cerebral palsy, cystic fibrosis, diabetes, epilepsy, fibromyalgia, heart disease,
Drugs
RLC Labs has recalled 483 lots of Nature-Throid and WP Thyroid because FDA testing of samples from six lots found them to be subpotent. “The product may have as low as 87% of the labeled amount of liothyronine or levothyroxine,” a recall notice says. Patients being treated for hypothyroidism
Devices
FDA has cleared an Avinger 510(k) for its TigerEye image-guided chronic total occlusion (CTO) crossing system. The device provides real-time imaging from inside the vessel during a CTO-crossing procedure, the company says. It is designed with an upgraded image capture that provides high definition, real-time
FDA Policy/General
Federal Register notice: FDA has determined for patent extension purposes the regulatory review period for Senseonics’ Eversense Continuous Glucose Monitoring System, indicated for continually measuring glucose levels in adults with diabetes for up to 90 days. The regulatory review period is 3,727 days, which includes 3,123 days that