Devices
FDA is launching a Digital Health Center of Excellence within CDRH. An online announcement says the launch “is an important step in furthering the agency’s overarching dedication to the advancement of digital health technology, including mobile health devices, software as a medical device, wearables when used as a medical
Drugs
A 2/26-3/10 FDA inspection at Coupler Enterprises, Warrington, PA, found significant violations of current good manufacturing practice (CGMP) regulations for finished pharmaceuticals. A 9/15 Warning Letter says specific violations were: * failing to inspect the packaging and labeling facilities immediately before use to assure that all drug
Drugs
FDA says it intends to amend its medical product intended use regulations that describe the types of evidence relevant to determining whether a product is intended for use as a drug or medical device under the law and implementing regulations, including whether an approved or cleared medical product is intended
FDA Policy/General
Federal Register notice: FDA has made available a draft guidance entitled Draft Guidance for Cannabidiol. The document provides product-specific recommendations on the information and data needed to demonstrate bioequivalence to support ANDAs for cannabidiol oral solution. To view the notice, click here.
FDA Policy/General
Federal Register notice: FDA has announced an 11/19 public meeting Webcast entitled “CBD and Other Cannabinoids: Sex and Gender Differences in Use and Responses.” The meeting is scheduled to discuss potential sex (biological) and gender (psychosocial) differences in use and responses to cannabidiol (CBD) and other cannabinoids. Presentations will
Drugs
FDA is alerting health care professionals and patients to a recall of all unexpired albuterol sulfate inhalation aerosol manufactured by Catalent Pharma Solutions for Perrigo Pharmaceutical Co. due to possible clogging of the inhaler resulting in patients not receiving enough or any medicine. The albuterol inhalers are used to treat
FDA Policy/General
FDA has posted its latest batch of Warning Letters. They can be accessed by clicking on the link following each letter. Coupler Enterprises, Warrington, PA (9/15): FDA inspected the firm in February and found significant GMP violations for finished pharmaceuticals. For example, Coupler failed to inspect the packaging and
Biologics
FDA is expected to issue a guidance later this week laying out tougher new standards for emergency authorization of a Covid-19 vaccine. The Washington Post says the new standards “will make it exceedingly difficult for any vaccine to be cleared before Election Day.” The Post article says the new
Devices
FDA has granted Spineology Inc. a de novo marketing authorization for its OptiMesh Expandable Interbody Fusion System. The grant follows completion of the company’s SCOUT (Spineology Clinical Outcomes Trial) study. “OptiMesh is a unique mesh device that expands in three dimensions, enabling surgeons to perform interbody fusion procedures through
Drugs
FDA has added content to a question-and-answer appendix in its guidance entitled Conduct of Clinical Trials of Medical Products during COVID-19 Public Health Emergency. The updated document includes a new question-and-answer regarding a clinical trial investigator’s responsibility to review all investigational new drug application
Devices
[Report by Jim Dickinson] Years of complaints about the adequacy of CDRH device labeling requirements are echoed in a new raft of complaints about the labeling of intrauterine devices (IUDs) implanted in an estimated 15 million American women. Most recent publicly available data show over 20,000 FDA-logged IUD
FDA Policy/General
Federal Register notice: FDA has made available a final guidance entitled “Investigational Covid-19 Convalescent Plasma.” On 8/23, the agency issued an emergency use authorization for convalescent plasma that requires the guidance’s replacement. The new document includes a discussion to facilitate the availability of investigational convalescent plasma when
FDA Policy/General
Federal Register notice: FDA has withdrawn a May-issued final guidance entitled “Investigational COVID–19 Convalescent Plasma” because the agency is issuing a new guidance under the same title. On 8/23, the agency issued an emergency use authorization for convalescent plasma that made the guidance obsolete. To view the
Drugs
Former FDA commissioner Scott Gottlieb says a recent move by HHS secretary Alex Azar to redirect his authority to prevent FDA and other health agencies from introducing any new rules on their own is a “distraction to FDA at the time that they should be focused on the Covid response.
Devices
FDA has approved a Simplify Medical PMA for its Simplify Artificial Disc for one-level disc replacement indications. The device’s approval is based on clinical data demonstrating that the device “achieved superiority to the fusion control on the composite primary endpoint,” the company says. The prospective trial enrolled 166
Devices
Becton, Dickinson says four previously announced recalls of its BD Alaris System have been classified as follows: 1. Alaris PC Unit Model 8015 Front Case with Keypad Replacement Kits (Class 1 recall): The pump module keypad may exhibit keys that are unresponsive or stuck as a result of fluid ingress,
Devices
CDRH has updated its public Manufacturer and User Facility Device Experience (MAUDE) database to improve transparency and analysis of medical device report (MDR) data. The update adds details on individual events included in summary reports for device registry exemptions in “comma-separated values” format. The update also allows for analyzing
FDA Policy/General
Consumer Organizations Sought for Advisory Panel Selections Federal Register notice: FDA seeks consumer organizations interested in participating in selecting voting or nonvoting consumer representatives to serve on its advisory committees or panels. 09/18/2020 Info Collection on Social Behavioral Sciences Data Federal Register notice: FDA seeks comments on a
FDA Policy/General
Molecular diagnostics company Biodesix has acquired Seattle-based Integrated Diagnostics on undisclosed terms. The transaction includes Integrated’s lead oncology product, XL2 test, which is intended to rule out cancer for patients with suspicious lung nodules. Becton, Dickinson and Co. has completed its acquisition of TVA Medical, which develops vascular
FDA Policy/General
Federal Register notice: FDA has submitted to OMB a proposed information collection entitled “Assessment of Terms and Phrases Commonly Used in Prescription Drug Promotion.” The proposed research involves assessing how consumers and primary care physicians interpret terms and phrases commonly used in prescription drug promotion, as well as those used
FDA Policy/General
Federal Register notice: FDA is seeking comments on a proposed study entitled “Medical Conference Attendees’ Observations About Prescription Drug Promotion.” The study is intended to focus on understanding the landscape of healthcare provider-directed promotion of prescription drugs at medical conferences and how elements of pharmaceutical booths in medical conference
FDA Policy/General
Federal Register notice: FDA is seeking comments on a proposed “Survey of Drug Product Manufacturing, Processing and Packing Facilities — 21 CFR parts 210 and 211.” The agency says the survey is intended to help it better understand how manufacturers, processors, and packers of drug products approach managing risks related to