Hall Render

JANUARY 30, 2025

According to the Final Guidance, if a firm follows FDAs recommendations and shares such information with HCPs, FDA would not consider this communication alone as evidence of the firms intention to promote the product for an unapproved use, nor does it require the firm to submit the communication to the Agency at the time of dissemination.

FDA 52

FDA State Policy Public Health Compliance 52

Bill of Health

SEPTEMBER 3, 2024

Food and Drug Administration (FDA) approved mifepristone to terminate a pregnancy over 20 years ago. Medication abortion, which typically includes a combination of mifepristone and misoprostol, is the most common , cost-effective, and least invasive type of abortion care available in the United States.

Medicaid 133

Medicaid Medicaid COVID-19 FDA 133

Drug & Device Law

JANUARY 15, 2024

We have discussed how exclusion of FDA compliance in pelvic mesh cases, based on a false equivalence between preemption and evidentiary admissibility, has hampered the defense in that litigation. In state court, Creazzo remains binding precedent. 3d 1245 (N.J. Blaw-Knox , 360 F.3d 3d 426, 431 n.3 Crown Equipment Co. ,

Compliance 52

Compliance FDA Governance State Policy 52