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FDA
Drug Utilization Management Impacts Physician Treatment Decisions,…
A study recently published in PLOS ONE found that drug utilization management impacts physician treatment decisions and can lead…
The Importance of Private Funding to Biopharmaceutical Development
In early September 2022, a study was published regarding The Relative Contributions of NIH and Private Sector Funding to the…
OPDP Releases Proposed Collections of Information Regarding DTC Advertising
The United States Food and Drug Administration (FDA) recently published several notices that the Office of Prescription Drug…
FDA Hosts Webinar on Real-World Evidence on Opioid Use
In mid-September 2022, the United States Food and Drug Administration (FDA) held a webinar on Real-World Evidence (RWE), providing…
FDA Releases Draft Guidance on Cancer Treatments
Earlier this year, the United States Food and Drug Administration (FDA) released draft guidance, Real-Time Oncology Review (RTOR)…
OPDP Works to Increase Transparency and Community Interaction
Throughout 2022, the United States Food and Drug Administration (FDA) Office of Prescription Drug Promotion (OPDP) has made…
FDA Issues Untitled Letter to Althera Over Roszet Promotions
In early June 2022, the United States Food and Drug Administration (FDA) sent an Untitled Letter to Althera Pharmaceuticals, LLC,…
CMS and FDA Show United Front on Aduhelm Approval and Coverage
Earlier this year, Centers for Medicare and Medicaid Services (CMS) Administrator Chiquita Brooks-LaSure and Food and Drug…
FDA Releases Draft Guidance on Benefit-Risk Principles
On May 10, 2022, FDA published draft guidance entitled, “Benefit-Risk Considerations for Product Quality Assessments”, which…
FDA Releases Guidance on Prescription Drug Importation
In May 2022, the United States Food and Drug Administration (FDA) issued a Final Guidance, Importation of Prescription Drugs Final…