FDA Aims To Improve Medical Device Security
The agency has issued proposed draft recommendations to guide incorporation of cybersecurity protections into medical devices at the time of manufacture.
FDA
FDA Warns of Potential Chemical Exposure With Certain Hemodialysis Machines
The source of the chemicals is from the silicone tubing used as a part of the hydraulics in the machine and the dialysate lines.
Use of Extrapolation Common in FDA New Drug Approvals
Extrapolation of the findings from pivotal clinical trials to the approved indication most common for disease severity
FDA Says No to Vadadustat Approval Due to Safety Concerns
The NDA submission included data from 36 clinical trials involving over 8000 patients.
Black Patients Still Underrepresented in Trials for New Drug Approvals
No improvement seen in representation of Black patients after implementation of a 2015 FDA action plan to improve diversity
FDA Approves Marketing of First Condom Designed for Anal Sex
Condom was approved through the De Novo premarket review pathway for low- to moderate-risk devices of a new type
FDA Approves Second COVID-19 Vaccine Spikevax
Findings from an ongoing randomized, placebo-controlled, observer-blind phase 3 trial showed Spikevax was 93.2% effective at preventing COVID-19.
FDA Warns Against Using At-Home COVID-19 Test Swabs in the Throat
Throat swabs are common in some countries, but most self-tests in the United States require nasal samples
FDA Shortens Time to Booster After Moderna Vaccine to 5 Months
Similar time window for boosters is already in place for people who received the Pfizer/BioNTech vaccine.
FDA Says Rapid At-Home COVID-19 Tests Not as Sensitive to Omicron
Agency says that antigen tests ‘do detect the omicron variant, but may have reduced sensitivity’
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