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FDA
FDA Proposes Reorganizing CDER Office of New Drugs
On June 4, the Food and Drug Administration (FDA) released additional information regarding the proposal to modernize the Center…
FDA Announces Pilot Program for Orphan Drug Submissions
The FDA had more than 700 orphan drug designation requests last year. As a result, the FDA recently announced a new pilot program…
FDA Publishes List of Drug Companies Allegedly Blocking Access to Drug…
The United States Food and Drug Administration (FDA) has recently publicized a list of forty-one branded drug companies that have…
FDA Plans Opioid Summit June 27, 2018
Recently, United States Food and Drug Administration (FDA) Commissioner Scott Gottlieb, M.D., announced a one day Online Opioid…
Fresenius Provides Insight As to Why It Terminated Acquisition of Akorn,…
On Wednesday, May 2, 2018, Fresenius made some allegations that shed light on why the company sought to terminate its acquisition…
FDA Issues Order Restricting Sales of Contraception Device
On April 9, 2018, the United States Food and Drug Administration issued an order restricting the sale and distribution of the…
Gottlieb Discusses Opioids and Lays Out Vision
On Wednesday, April 4, 2018, Food and Drug Administration (FDA) Commissioner Scott Gottlieb spoke at the National Rx Drug Abuse…
OPDP Sends First Untitled Letter of 2018
Here we are…barely finished with the first quarter of 2018, and the United States Food and Drug Administration (FDA) Office of…
FDA Plans to Review Promotional Research
According to new releases from the FDA, it plans to look at several issues related to biopharma advertising and promotion. FDA is…
Gottlieb Discusses Opioids and Lays Out Vision – Google it’s…
On Wednesday, April 4, 2018, Food and Drug Administration (FDA) Commissioner Scott Gottlieb spoke at the National Rx Drug Abuse…