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FDA
FDA Releases Final Guidance on Medical Product Communications and Labeling
Recently, the United States Food and Drug Administration (FDA) released “Medical Product Communications That Are Consistent With…
FDA Publishes Draft Guidance on Expanding 510(k) Pathway
A draft guidance recently issued by the United States Food and Drug Administration (FDA) sets the stage for how an existing 510(k)…
FDA Prepares for OND Modernization
On Friday, May 4, 2018, United States Food and Drug Administration (FDA) Commissioner Scott Gottlieb, MD, discussed plans to…
FDA Final Guidance: Drug and Device Manufacturer Communications with…
FDA recently announced the availability of an important guidance for industry. The document, “Drug and Device Manufacturer…
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…