The FDA Law Blog

MAY 13, 2024

This guidance, when finalized, will replace the original version of this document finalized in 2017. Based on a review of premarket submissions made in 2012 through 2019, FDA identified 90 examples of 510(k)s, De Novos, HDEs, and PMAs approved/cleared which utilized RWE in support of regulatory decision-making.

FDA 109

FDA Medical Records Documentation 109

Hospital Pharmacy Europe

AUGUST 7, 2024

The incidence of medication errors varies greatly among published studies, not only due to the lack of a clear definition, 1,2 but also because of different factors such as the healthcare setting, differing levels of automation (e.g. 3–5 Medication errors are often documented in national or local electronic incident reporting systems.

Hospitals 98

Hospitals Documentation Medical Records Dosage 98

The Checkup by Singlecare

OCTOBER 16, 2023

Below, we detail the 14 categories of conditions that qualify for SSA disability in adults and what you may be expected to provide for documentation for each. The SSA also requires persuasive medical documentation from a healthcare provider. (This is not to be confused with Medicare Part A and Part B.)

Documentation 105

Documentation Immunization Mayo Clinic Insurance 105

Hospital Pharmacy Europe

JANUARY 18, 2023

Dermatology correspondence (as part of the medical record) were examined as far back as 2012 if necessary for relevant information about patients’ treatment. Relevant data (patient demographics and treatment details) were imported into Excel by a member of the pharmacy team. Conclusion.

Hospitals 52

Hospitals Medical Records Documentation Pharmaceutical Companies 52