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FDA
Eli Lilly is the Recipient of the First OPDP Untitled Letter of 2022
On January 19, 2022, the United States Food and Drug Administration (FDA) Office of Prescription Drug Promotion (OPDP) sent an…
FDA Issues Two Draft Guidance Documents on Real-World Data
At the end of 2021, the United States Food and Drug Administration (FDA) issued two draft guidance documents that outline the…
Becerra Reinstates FDA Rulemaking Authority
On August 30, 2021, Health and Human Services (HHS) Secretary Xavier Becerra issued a Notice that reversed former HHS Secretary…
FDA Revises COVID-19 ANDA Guidance
In early September 2021, the United States Food and Drug Administration (FDA) revised its Development of Abbreviated New Drug…
CME/CNE/CPE Medical Education Program Helps Physicians Integrate the FDA…
Leading continuing medical education provider, Rockpointe, in conjunction with Boston University and Potomac Center for Medical…
FDA Updates Final Guidance on Biosimilar Development
Recently, the United States Food and Drug Administration (FDA) finalized additional questions and answers related to biosimilar…
CMS Wants to Repeal MCIT Final Rule
In September 2021, the Centers for Medicare and Medicaid Services (CMS) issued a proposed rule that would withdraw a Trump-era…
FDA Issues Draft Guidance on RWD Sourced from EHRs and Medical Claims Data
In late September 2021, the United States Food and Drug Administration (FDA) issued draft guidance, Real-World Data: Assessing…
FDA REMS Pain Management and Opioid Therapy: Persistent Knowledge Gaps…
The opioid epidemic that has gripped the US for over 20 years has worsened during the ongoing COVID-19 pandemic with the highest…
FDA Requests Input on How to Handle Post-Approval Regulation of PANDAs
The US Food and Drug Administration (FDA) recently asked for input from stakeholders on how it should handle certain drugs…