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FDA
MannKind Corporation Receives Warning Letter from Facebook Post
On October 5, 2018, the Office of Prescription Drug Promotion (OPDP) of the United States Food and Drug Administration (FDA)…
FDA Releases Set of Guidances on Transdermal and Topical Delivery Systems
The Food and Drug Administration (FDA) released a pair of guidance documents intended to advance the development of generic drugs…
FDA Publishes Guidance on Product Identifiers Under the Drug Supply Chain…
In September, FDA published “Product Identifiers Under the Drug Supply Chain Security Act: Questions and Answers Guidance for…
CDC Releases a Guide on Implementing Opioid Guidelines – But Is A Showdown…
On September 21, 2018, the Centers for Disease Control (CDC) issued a publication, “Implementing the CDC Guidelines for…
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…