FDA Law

DECEMBER 16, 2024

Lenz, Principal Medical Device Regulation Expert FDA recently released 510(k) Third Party Review Program and Third Party Emergency Use Authorization (EUA) Review which finalizes the draft guidance of the same title issued in December 2023. By Adrienne R.

Consulting 52

Consulting Manufacturing Utilities Provider 52

CDOCS

MAY 4, 2021

We need to recognize how clinical dentistry has become intertwined with digital technologies to synergistically assist us in providing enhanced diagnosis with safe and predictable treatment outcomes. & Intra-oral photographs were taken and after reviewing his medical history we discussed his desires for a fixed replacement of these teeth.

Patient-Centered 52

Patient-Centered Patients Manufacturing Provider 52

FDA Law

OCTOBER 14, 2021

Rather, FDA seems intent on regulating RAS devices almost as if they were therapeutics responsible for long term clinical outcomes. It is well out of bounds for FDA to regulate them as if they were a determinant of long term clinical outcomes. Gone are the days of tool type indications for this type of device. 21 U.S.C. §

Patient-Centered 52

Patient-Centered Healthcare Manufacturing Provider 52

GeriPal

MAY 5, 2022

Was there any mention about the impact that hearing loss has in communication or what we should do about it in clinical practice? Association of Sensory and Cognitive Impairment With Healthcare Utilization and Cost in Older Adults. And he is also a clinical audiologist, which is going to be key for this podcast. Transcript.

IT 102

IT Screening Hospital Clinic 102

FDA Law

SEPTEMBER 20, 2021

STAR aims to facilitate earlier access to novel uses of existing therapies for patients with a serious condition with unmet medical needs. The sponsor then gets the review ball rolling by submitting all of the efficacy supplement minus the final clinical study reports and clinical summaries.

Patient-Centered 52

Patient-Centered Manufacturing Clinic Provider 52

FDA Law

DECEMBER 11, 2023

6] It is inconsistent to say that LDTs must be regulated as medical devices because of the newness of the tests and then reduce the cost of the proposed regulation by declaring that half of all LDTs will be exempt from premarket review. FDA, Performance Report to Congress: Medical Device User Fee Amendments FY 2022, at 13-18, [link]. [14]

IT 69

IT Medical Patient-Centered Provider 69

FDA Law

AUGUST 3, 2022

3, 1992) (“It has come to the attention of FDA that laboratories have been manufacturing, “home brew” products, either from products already on the market, or from components, and utilizing these unapproved products for diagnostic purposes. That growth has, unsurprisingly, led to different views about regulation of LDTs.

Lab Testing 98

Lab Testing Government IT Manufacturing 98

FDA Law

FEBRUARY 22, 2022

The good news is that the NIH’s program is real and has been offering helpful assistance to manufacturers seeking to obtain Emergency Use Authorization (EUA) approval from FDA for OTC rapid antigen tests. The NIH screens manufacturers to ensure they have reputable tests already in use in other countries with good supporting test data.

Manufacturing 52

Manufacturing Screening Provider Clinic 52

FDA Law

JUNE 2, 2023

Most are new or revised definitions and administrative changes, but several proposals represent new policies that should be of concern to drug manufacturers. Price Transparency Surveys The MDRP statute requires manufacturers to submit only three prices: average manufacturer price (AMP), best price, and nominal prices.

Manufacturing 59

Manufacturing Vaccination Government Diagnosis 59

FDA Law

JUNE 1, 2025

Senator Durbins letter references a January 2023 study from the Journal of the American Medical Association, which found that more than two-thirds of drugs advertised on television were considered to have low therapeutic value. Maximizing patient clinical outcomes and quality of life may ultimately minimize healthcare resource utilization.

Healthcare Professional 59

Healthcare Professional Manufacturing Healthcare Utilities 59