FDA Archives - Page 79 of 103 - Medical Design Sourcing

More than 50 medtech testing sites win FDA pilot accreditation

The FDA announced today that more than 50 laboratory sites were chosen to participate in its program for streamlined regulatory reviews.

In total, 53 sites made the FDA’s initial list for participation in its Accreditation Scheme for Conformity Assessment (ASCA) program, which will set out to support more streamlined regulatory reviews of medical device market applicants’ compliance to voluntary consensus standards, according to a news release.

All sites selected by the FDA are designated to perform basic safety and essential performance testing to ANSI/AAMI 60601-1 as well as IEC 61010-1 standards for medical devices undergoing 510(k) and other premarket submissions. Also included in the ASCA program is testing to biocompatibility standards such as ISO 10993, although no labs that are currently on the FDA list has been designated to provide such testing at this time.

Cook Research Incorporated (CRI), a part of Cook Medical, was one of the 53…

Pfizer to boost vaccine production for U.S. by 10%

Image courtesy of Wikipedia

Pfizer will deliver 10% more of its COVID-19 vaccine to the U.S. by the end of May than originally planned, its CEO tweeted yesterday.

The tweet follows the federal government’s decision to recommend a temporary halt in the distribution of Johnson & Johnson’s single-dose vaccine, which has been tied to rare instances of blood clot formation in women.

Pfizer will deliver 220 million doses of its two-dose vaccine by the end of May and supply the full 300 million it agreed to for the end of July two weeks early, CEO Albert Bourla tweeted. “In the fight against COVID-19, we’re in this together,” he added.

Get the full story on our sister site, Drug Discovery & Development.

Pfizer to boost vaccine production for U.S. by 10%

Image courtesy of Wikipedia

Pfizer will deliver 10% more of its COVID-19 vaccine to the U.S. by the end of May than originally planned, its CEO tweeted yesterday.

The tweet follows the federal government’s decision to recommend a temporary halt in the distribution of Johnson & Johnson’s single-dose vaccine, which has been tied to rare instances of blood clot formation in women.

Pfizer will deliver 220 million doses of its two-dose vaccine by the end of May and supply the full 300 million it agreed to for the end of July two weeks early, CEO Albert Bourla tweeted. “In the fight against COVID-19, we’re in this together,” he added.

As of Monday, more than 6.8 million doses of the J&J single-dose vaccine had been administered in the U.S. Among recipients of those doses, six cases of a rare and severe type of blood clot have been reported. The CDC and FDA are reviewi…

Researcher: Neuroinflammation may be behind tinnitus reports in some COVID-19 vaccine recipients

Photo by Mark Paton on Unsplash

Peripheral cytokines from COVID-19 vaccines could cause or exacerbate tinnitus, or ringing in the ears, theorized Shaowen Bao, an associate professor of neuroscience and physiology at the University of Arizona.

Recent articles on Drug Discovery & Development on the possible link between tinnitus and COVID-19 vaccines have attracted hundreds of comments.

Some 0.65% of COVID-19 vaccine recipients who filed reports in CDC’s Vaccine Adverse Event Reporting System (VAERS) reported the issue. Although VAERS is not exhaustive, those 369 reports out of a total of 56,722 VAERS entries represent a tiny fraction of 190 million COVID-19 vaccine doses that have been administered in the U.S. to date.

Six volunteers in J&J’s Phase 3 trial for its COVID-19 vaccine complained of tinnitus. FDA, however, concluded there was insufficient evidence to link the issue t…

6 assumptions about COVID-19 vaccines as AstraZeneca and J&J face safety scrutiny

[Photo by Daniel Schludi on Unsplash]

With COVID-19 cases surging in many parts of the world, the need is high for multiple vaccines to slow the virus.

But the fate of adenovirus-vectored vaccines from AstraZeneca and Johnson & Johnson has become murky after a limited number of people receiving those vaccines have developed blood clot disorders.

Officials in both the EU and the U.S. suspect there could be a link between adenovirus-based COVID-1 vaccines and blood clotting problems such as cerebral venous sinus thrombosis. Authorities in both countries have either temporarily halted or constrained the use of adenovirus vaccines.

Russia’s Sputnik V and China’s CanSino Biologics also have COVID-19 vaccines based on an adenovirus platform.

1. The blood clotting problems seems rare but more common in women

Even though blood clotting problems have gotten a substantial amount of att…

Feds halt J&J COVID-19 vaccine due to blood clot concern

The FDA and CDC issued a joint statement today recommending the pause in the administration of the Johnson & Johnson COVID-19 vaccine.

As of yesterday, more than 6.8 million doses of the J&J single-dose vaccine had been administered in the U.S. Among recipients of those doses, six cases of a rare and severe type of blood clot have been reported. The CDC and FDA are reviewing data involving these cases.

Get the full story at our sister site, Drug Discovery & Development.

Feds halt Johnson & Johnson COVID-19 vaccine due to blood clot concern

The FDA and CDC issued a joint statement today recommending the pause of administration of the Johnson & Johnson COVID-19 vaccine.

As of yesterday, more than 6.8 million doses of the J&J single-dose vaccine had been administered in the U.S. Among those doses, there have been six reported U.S. cases of a rare and severe type of blood clot in individuals who received the vaccine. The CDC and FDA are reviewing data involving these cases.

In such cases, a form of blood clot known as cerebral venous sinus thrombosis (CVST) was seen in combination with low levels of blood platelets (thrombocytopenia), according to the joint statment. All six cases were in women between ages 18 and 48, with symptoms occurring between six and 13 days after vaccination.

Treatment for CVST is different from that which may typically be administered, which is an anticoagulant drug called heparin. In these cases, heparin may be dangerous and alternative treatments are needed,…

Genentech wins FDA approval for Xolair prefilled syringe

Genentech announced today that the FDA approved its supplemental biologics license application for the Xolair prefilled syringe.

South San Francisco-based Genentech touts the Xolair (omalizumab) prefilled syringe for self-injection across all approved U.S. indications as the only FDA-approved biologic designed to target and block immunoglobulin E (IgE) for treating moderate to severe persistent allergic asthma, chronic idiopathic urticaria (CIU) and nasal polyps, according to a news release.

Get the full story at our sister site, Drug Delivery Business News.

FDA slaps Class I label on rapid infuser recall

The FDA today declared that the recall of an emergency infusion device kit is the most serious type.

The recall covers three models of disposable sets made by Smisson-Cartledge Biomedical for its ThermaCor 1200 rapid infuser, which is used for fluid or bolus delivery. The system is made of a footswitch for hands-free fluid control, a fluid delivery device and a single-use disposable set with supply lines that can be used with intravenous (IV) bags or surgical equipment, according to the FDA.

Get the full story on our sister site, Medical Design & Outsourcing.

FDA issues EUA for single-use, OTC PCR COVID-19 at-home test

Lucira Health announced today that it received FDA emergency use authorization (EUA) for over-the-counter sales of its COVID-19 test kit.

Emeryville, Calif.-based Lucira’s PCR molecular test kit, the Lucira Check It kit, is designed to deliver results in 30 minutes or less at home. The authorization covers those with symptoms and those without, and the test kit can be ordered for $55, according to a news release.

The company’s COVID-19 testing kit was the first to receive EUA for at-home use back in November, although that authorization was for prescription use only. The latest authorization drastically expands the availability of the test. It follows the FDA’s recent authorizations of the BinaxNow Ag card from Abbott (which includes point-of-care screening) and the Quidel Quick-View at-home test for OTC use.

Each Lucira test kit can detect a positive result in as few as 11 minutes or confirm a negative result within 30 minutes, the com…

AI-aided colon cancer tech gets FDA nod

Cosmo Pharmaceuticals announced today that it received marketing authorization for its GI Genius AI-based lesion detecting system.

GI Genius is an intelligent endoscopy system that uses AI/machine learning to detect lesions in the colon such as polyps or suspected tumors in real-time during a colonoscopy, according to a news release.

The device, which received FDA approval through the de novo pathway, is compatible with all endoscopes. Cosmo is the sole manufacturer, while Medtronic is the exclusive worldwide distributor.

Made up of hardware and software designed to highlight portions of the colon, the device uses AI algorithms to identify regions of interest where it may detect a potential lesion. GI Genius generates markers, which appear as green squares and are accompanied by a short, low-volume sound. It superimposes them on the video from the endoscope camera when a potential lesion is identified.

The device’s signals alert a clinician …

Analyzing FDA guidance on DDI studies for therapeutic proteins

Photo by Myriam Zilles on Unsplash

The co-administration of drugs is commonplace for therapeutic proteins (TP). Yet, drug developers may face delays or ambiguity in preparing for clinical trials if they don’t plan for preliminary analysis of drug-drug interactions (DDI). Fortunately, the U.S. Food and Drug Administration (FDA) released in August 2020 new draft guidance for DDI assessment of TPs. The resulting shift in DDI experimental design and criteria will require teams to take a risk-based testing approach to accurately predict the effects of DDIs during future in-human trials.

DDI studies provide a preliminary analysis and risk potential for drug developers compiling Investigational New Drug (IND) applications and candidates of Biologics License Applications (BLA), though the new guidance is recommended but not required. By applying the insights provided by this guidance, developers can achieve a …