FDA Policy/General
While declining to intervene in a whistleblower case involving Trividia Health blood glucose meters, the Department of Justice (DoJ) has filed a “statement of interest” with a Florida federal court that provides a “vigorous defense” of the “fraud-on-FDA” theory of liability. Writing in Sidley’s False Claims Act
Drugs
An FDA consumer update cautions that some products marketed for removing moles and other skin lesions can cause injuries and scarring. The online post says there currently are no FDA-approved prescription or over-the-counter drugs to treat moles, seborrheic keratoses, or skin tags. “But,” it says, “there are
Devices
FDA has approved a Foundation Medicine PMA for its FoundationOne CDx to be used as a companion diagnostic for the two approved indications for Genentech’s Rozlytrek (entrectinib). In 2019, FDA approved Rozlytrek for treating adult and adolescent patients whose cancers have the specific genetic defect NTRK (neurotrophic tyrosine receptor
Drugs
The International Society for Pharmaceutical Engineering (ISPE) says it recognizes and thanks FDA for applying the lessons learned from the pilot Quality Metrics Site Visit Program and the Quality Metrics Feedback Program in developing an agency quality metrics reporting program proposal. In a comment letter, ISPE raises issues relating to
Drugs
FDA has released the FDA-483 issued following a 4/19-4/30/21 inspection at BPI Labs, a Largo, FL, sterile drug manufacturer and outsourcing facility. The five inspection observations were: * equipment used in the manufacture, processing, packing, or holding of drug products is not of appropriate design to
Biologics
Some 18 members of Congress led by Sen. Ted Cruz (R-TX) have written to FDA commissioner Robert Califf and the agency’s Vaccines and Related Biological Products Advisory Committee with questions about emergency use authorizations (EUA) for Covid-19 vaccines in children under age 5. A statement (contains a
Drugs
University of Kentucky researchers say FDA, large buying groups, and the Defense Department should consider alternative strategies the researchers have developed for monitoring drug quality. Writing in the Journal of Pharmaceutical Innovation, the researchers say that since FDA began monitoring the quality of pharmaceutical manufacturing by enforcing current good manufacturing
Biologics
Fresh off a positive FDA advisory committee vote (see earlier story) to recommend an emergency use authorization of its Covid-19 vaccine, Novavax now finds its vaccine stalled at the agency because of last minute manufacturing data the company submitted, which have to be reviewed before the agency renders a
Drugs
A bipartisan group of eight senators is asking the U.S. Patent and Trademark Office (USPTO) to take steps to eliminate patent thickets — the many patents that cover a single product or minor variations on a single product. In a 6/8 letter, the senators say patent thickets “harm competition
Drugs
FDA has denied most of a 9/18/17 petition submitted by the Post-Finasteride Syndrome Foundation seeking immediate removal from the market of Propecia and all its generic forms or significant labeling changes. However, the agency did agree to order a few labeling changes. The 43-page denial letter
FDA Policy/General
The U.S. House of Representatives last night (6/8) voted 392 to 28 to pass the Food and Drug Amendments of 2022, which would reauthorize FDA user fee programs for prescription drugs, generic drugs, biosimilars, and medical devices. The measure is also intended to modernize certain programs (see earlier
Devices
FDA has given a Class 1 designation to a recall of GE Healthcare’s ventilator batteries used in certain Carescape R860 Ventilators due to insufficient battery backup power resulting in premature shutdown of the ventilator when not connected to an AC power supply. Affected devices were initially recalled 4/18
FDA Policy/General
Federal Register notices: FDA has renewed the charters for four advisory committees for an additional two years. They are: * Drug Safety and Risk Management Advisory Committee’s new charter will be in effect until 5/31/2024 (see notice). * Peripheral and Central Nervous System Drugs Advisory Committee’s new charter
FDA Policy/General
Federal Register notice: FDA has submitted to OMB an information collection extension entitled “New Animal Drug Applications and Veterinary Master Files.” The collection supports agency regulations that establish format and content requirements regarding new animal drug application submissions, and other animal drug-related submissions. To view the notice, click here.
Biologics
Moderna says its Omicron-containing bivalent Covid vaccine booster candidate “met all pre-specified endpoints including superior neutralizing antibody response against the Omicron variant one month after administration” when compared to the original Moderna vaccine. A company statement says the Omicron booster was generally well-tolerated, with side effects comparable
Drugs
CDER has published a Manual of Policy and Procedures (MAPP), Assessment of the User Interface of a Drug-Device Combination Product Submitted in a Pre-ANDA Communication or an ANDA, to describe how the Office of Generic Drugs (OGD) and the Office of Surveillance and Epidemiology (OSE) will assess the
Drugs
Members of the Senate have introduced the Affordability is Access Act “to ensure that people across the country can access and afford over-the-counter birth control options and plan their own reproductive lives on their own terms.” Senate HELP Committee chair Patty Murray (D-WA) says the act would
Drugs
Writing for the Global Forum, authors from 12 major drug companies say it is time to apply the sense of urgency that was used to quickly develop Covid-19 vaccines and treatments to other diseases of significant public health burden. “Cardiovascular and neurological diseases are both associated with even greater
Drugs
The Association for Accessible Medicines (AAM) says FDA’s proposed potential new direction for a quality metrics reporting program may not align with five principles the association described in a 3/10/21 white paper submitted to FDA. In a 6/3 comment letter, AAM says it’s concerned that
Devices
FDA says the Medtronic 4/11 recall of 1,614 HeartWare Ventricular Assist Device pump implant kits is Class 1. An agency notice says the affected devices were distributed between 10/11/06 and 6/3/21. Medtronic recalled the kits due to a pump weld defect. If the issue
Devices
Sens. Roger Marshall (R-KS) and Mike Braun (R-IN) have introduced S. 4349 to amend the Federal Food, Drug, and Cosmetic Act to add limitations on how notifications are made about potentially harmful medical devices. The bill says that any such notification should include a description of the applicable
Drugs
FDA has approved Sanofi’s Dupixent (dupilumab) for children aged six months to five years with moderate-to-severe atopic dermatitis whose disease is not adequately controlled with topical prescription therapies or when those therapies are not recommended. Approval is based on data that include a Phase 3 trial evaluating