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FDA
FDA Looking to Make Changes to 510(k) Process
On November 26, 2018, United States Food and Drug Administration (FDA) Commissioner Scott Gottlieb announced changes to the…
FDA Announces New Efforts to Hold Industry Accountable for Fulfilling…
On November 16, 2018, the United States Food and Drug Administration (FDA) announced that the agency plans to soon publish a…
FDA Launches New Cell Phone App
On November 6, 2018, the United States Food and Drug Administration (FDA) announced a new app, the MyStudies app. The MyStudies…
Will FDA Crack Down on Opioid Approval Process?
In a statement released on November 2, 2018, accompanying the approval of Dsuvia, a new opioid analgesic, United States Food and…
FDA Releases Draft Guidance on Treatments for Rare Diseases
The U.S. Food and Drug Administration (FDA) released new draft guidance to assist sponsors of treatments for rare diseases in…
Second Letter from OPDP Issued Regarding the Bad Ad Campaign
We recently wrote about the Warning Letter MannKind Corporation received from the Office of Prescription Drug Promotion (OPDP) of…
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…