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Federal Register notice: FDA has withdrawn a May-issued final guidance entitled “Investigational COVID–19 Convalescent Plasma” because the agency is issuing a new guidance under the same title.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
Devices
FDA has cleared a 410 Medical 510(k) for its LifeFlow device for rapid delivery of blood and blood components, in addition to its previous clearances for crystalloid and colloid resuscitative fluids. The device is intended for treating severe hemorrhage, which is a leading cause of preventable death from trauma
Drugs
FDA has made “modernized” changes to its Phonetic and Orthographic Computer Analysis (POCA) program, the agency’s software tool that uses an advanced algorithm to determine the orthographic and phonetic similarity between two drug names. “The program can compare a drug name against multiple drug names found in several different
FDA Policy/General
House Energy and Commerce Committee leadership has denounced the White House after it blocked FDA commissioner Stephen Hahn from testifying before the committee this month about potential political interference into Covid-19 response efforts. “The American people deserve to hear Commissioner Hahn’s response to those concerns during a public
Drugs
Medimetriks Pharmaceuticals says it received a Type C Meeting written response from FDA on MM36 (difamilast) for the topical treatment of mild to moderate atopic dermatitis (AD). Based upon the response, Medimetriks says it is preparing to conduct a single pivotal trial in the U.S. for an NDA, which
Drugs
FDA has granted Junshi Biosciences an orphan drug designation for toripalimab and its use in treating soft tissue sarcoma. This is the third such designation granted to Toripalimab, with earlier designations for treating mucosal melanoma and nasopharyngeal carcinoma. Soft tissue sarcoma is a rare heterogeneous tumor with complex pathological types
FDA Policy/General
The CDER Office of Prescription Drug Promotion (OPDP) is planning to question healthcare providers about their view of prescription drug promotion in exhibit halls at medical conferences. A Federal Register notice says the research will look specifically at how elements of pharmaceutical booths in medical conference exhibit halls affect healthcare
Devices
FDA has published comparative performance data for more than 55 authorized molecular diagnostic Covid-19 tests against a standardized sample panel provided by the agency. An FDA statement says it provided the reference panel to test developers who are required to assess their tests’ performance against the panel or other
Devices
FDA has cleared a Acutus Medical 510(k) for the second-generation AcQMap 3D imaging and mapping catheter. The device combines 48 ultrasound transducers responsible for creating an “anatomical geometry” and 48 engineered electrodes which enable “electrical activation patterns” to be displayed along the inner surface of the heart. “Compatible
Biologics
Former FDA associate commissioner for public health strategy and analysis Peter Lurie says industry data showing that only 10% to 14% of compounds entering human testing in the last several decades were ultimately approved should be used to caution the public not to expect that all Covid-19 vaccines will
FDA Policy/General
Federal Register notice: FDA is proposing to reclassify Class 3 cytomegalovirus deoxyribonucleic acid (DNA) quantitative assay devices intended for transplant patient management into Class 2 (general controls and special controls), subject to premarket notification. FDA is also proposing a new device classification regulation with the name “quantitative cytomegalovirus nucleic acid