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Guidelines
FDA Issues Guidance Documents to Streamline Premarket Review and Approval…
The United States Food and Drug Administration (FDA) recently issued two guidances as part of its Drug Competition Action Plan…
ONC Finalizes Changes to Information Blocking Rules
On December 13, the Office of the National Coordinator for Health Information Technology (ONC) finalized changes to the…
FDA Releases Finalized Guidance on Use of Real-World Data in New Drug and…
Recently, the United States Food and Drug Administration (FDA) finalized two guidance documents that outline how sponsors can use…
Pharmaceutical Industry Pushes Back on Draft Guidance Issued by FDA Over…
Towards the end of last year, the United States Food and Drug Administration (FDA) issued a draft guidance that revisited its…
21st Century Cures Proposed Rule on Information Blocking Published
Recently, the U.S. Department of Health and Human Services (HHS) Office of the National Coordinator for Health Information…
Proposed Changes for the Mental Health Parity and Addiction Equity Act
Recently, the Departments of Labor, Health and Human Services, and the Treasury announced proposed changes to the Mental Health…
10th Annual Mood Disorders Summit 2023 Covers MDD in Special Populations;…
With the recent White House announcement to increase enforcement of the Mental Health Parity and Addiction Equity Act finally…
HHS OIG Publishes FAQ and Advisory Opinion on Cash, Cash Equivalents, and…
Recently, the United States Department of Health and Human Services Office of Inspector General (HHS OIG) published a new…
Stakeholders Provide Insight to CDER on Educational Needed in Rare Disease…
The United States Food and Drug Administration (FDA) Center for Drug Evaluation and Research (CDER) recently sought comments on…
SAMHSA Publishes FAQs on Removal of X-Waiver Requirement
Recently, the Substance Abuse and Mental Health Services Administration (SAMHSA) published frequently asked questions about the…