FDA Law Blog: Biosimilars

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.

Medical Records 111

Medical Records Documentation 111

RX Note

MARCH 14, 2023

Often, to find a quick answer for the antibiotic for a certain infectious disease, I will look up National Antimicrobial Guideline, 2019 or Sanford Guide to Antimicrobial Therapy. Example of patients with altered pharmacokinetics (e.g. before the availability of culture or susceptibility testing result).

Medical Records 52

Medical Records Hospitals Documentation 52

FDA Law Blog: Biosimilars

OCTOBER 2, 2023

The new guidance is one of three policy documents dedicated to explaining FDA’s interpretation of this statutory authority and their approach to exercising scientific judgment in evaluating drug effectiveness. We are heartened to see that this latest guidance reflects many of the advances we observed in practice since 2019.

Drug Development 64

Drug Development Documentation Labelling Medical Records 64

PharmaShots

JUNE 2, 2023

Coding errors will most likely lead to n claim denials and delayed payments if medical necessity is not correctly represented or coding guidelines and best practices were not followed. THYNK assists in patient eligibility & pre-approval checks adding to it medical necessity & documentation checks.

Insurance Coverage and Processing 40

Insurance Coverage and Processing Health and Personal Care Stores Medical Records Documentation 40

Pharmaceutical Technology

JUNE 20, 2023

GlobalData forecasts that the market for AI platforms for the entire healthcare industry will reach $4.3bn by 2024, up from $1.5bn in 2019 [i]. Consent documents often describe technical medical conditions and regulatory bodies are increasing pressure on sponsors to ensure that patient-facing information can be easily understood by patients.

Medical Records 52

Medical Records Documentation Communication Dosage 52