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FDA
Cavazzoni Appointed Director of CDER
Earlier this year, Patrizia Cavazzoni, MD, was named the Director of the United States Food and Drug Administration’s Center for…
CDER Largely Maintained User Fee Goals Through COVID-19 Pandemic
As many others experienced with the COVID-19 pandemic, the United States Food and Drug Administration’s (FDA’s) Center for Drug…
FDA Reopens Study on Naming of Pharmaceutical Drugs
Earlier this year, the United States Food and Drug Administration (FDA) reopened a proposed study to understand the way drug names…
CDRH Report Provides Examples of Real-World Evidence in Medical Device…
Recently, the United States Food and Drug Administration’s (FDA) Center for Devices and Radiological Health (CDRH) issued a report…
FDA Unveils Data Modernization Plan
In early March 2021, the United States Food and Drug Administration (FDA) unveiled its Data Modernization Action Plan (DMAP), an…
FDA to Focus on Patients with Rare Diseases
On March 5, 2020, in recognition of Rare Disease Day, the United States Food and Drug Administration (FDA) held a conference…
2020 OPDP Year-in-Review
The United States Food and Drug Administration’s (FDA) Center for Drug Evaluation and Research’s (CDER) Office of Prescription…
FDA Meets All Goal Dates for 2020 Drug Approvals
In 2020, the United States Food and Drug Administration (FDA) not only met all goal dates for approvals by the Center for Drug…
FDA Issues Guidance on STeP
Earlier this year, the United States Food and Drug Administration (FDA) finalized guidance for devices and combination products,…
Review of 2020 FDA Enforcement Activities
Recently, the attorneys at Ropes & Gray wrote an article reviewing the United States Food and Drug Administration’s (FDA) 2020…