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FDA
FDA Holds Public Meeting on Biosimilar Action Plan
On September 4, 2018, the United States Food and Drug Administration (FDA) held a public meeting to gather stakeholder input on…
July 2018 Record High Month for Generic Drug Approvals
The United States Food and Drug Administration (FDA) approved – or tentatively approved – a record of 126 generic drugs in July…
FDA Set to Hold Hearing on the Future Format of the National Drug Code
The United States Food and Drug Administration (FDA) has set a public hearing and an opportunity for public comment regarding the…
FDA Creating New Drug Shortage Task Force
The United States Food and Drug Administration (FDA) recently announced the creation of a new drug shortage task force, led by…
Final Opioid REMS Guidance and New FDA Education Blueprint Released
On September 18, 2018, the United States Food and Drug Administration (FDA) approved the final Opioid Analgesic Risk Evaluation…
FDA Remains Focused on Opioid Crisis, New Guidance Developing
Recently, the United States Food & Drug Administration (FDA) Commissioner Scott Gottlieb released a statement highlighting the…
FDA to Study Disclosures in Prescription Drug Advertisements
The United States Food and Drug Administration (FDA) laid out plans in an August 9, 2018, Federal Register publication to conduct…
Gottlieb Highlights New Steps to Guide Opioid Prescribing
On August 22, 2018, United States Food and Drug Administration (FDA) Commissioner Scott Gottlieb, M.D., released a statement on…
FDA Issues Draft Guidance on Gathering Patient Input
On June 13, 2018, the United States Food and Drug Administration (FDA) issued draft guidance, “Patient-Focused Drug Development:…
FDA Releases Two Draft Guidance Documents on REMS
In May 2018, the United States Food and Drug Administration (FDA) issued two draft guidance documents focused on developing a…