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FDA
2022 FDA New Drug Approvals Lowest Since 2016
In 2022, the United States Food and Drug Administration (FDA) Center for Drug Evaluation and Research (CDER) approved 37 new drugs…
Two Biotech Executives Charged in Securities Fraud Scheme
Two former executives were recently indicted for schemes to defraud investors in CytoDyn, Inc. The executives, Nader Pourhassan,…
FDA Receives Increased Budget for FY 2023
The omnibus spending bill passed by Congress in December 2023 includes funding and direction for the United States Food and Drug…
Congressional Report Released on FDA’s Improper Actions in Aduhelm Approval…
Following an 18-month investigation, House of Representatives Oversight and Reform Committee Chairwoman Carolyn Maloney and Energy…
Omnibus Bill Includes Changes to Pharmaceutical and Device Investigational…
The omnibus spending bill that passed Congress shortly before Christmas 2022 included legislation that was previously introduced…
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FDA Releases Draft Guidance on Cancer Treatments
Earlier this year, the United States Food and Drug Administration (FDA) released draft guidance, Real-Time Oncology Review (RTOR)…