FDA Preliminary Review Finds No Evidence of Suicidal Thoughts Linked to Weight-Loss Drugs
In a recent development, the U.S. Food and Drug Administration (FDA) reported that its preliminary review did not uncover any…
You searched for: FDA
FDA’s Abortion Drug Access Expansion Faces Criticism from 5th Circuit, SCOTUS Decision Looms
The 5th U.S. Circuit Court of Appeals in New Orleans has criticized the U.S. Food and Drug Administration (FDA) for…
Venable Expands FDA Group in Washington with Addition of Partners Kelly and Coen
Venable has announced the appointment of Jeremiah Kelly and Justin Coen as partners in the firm's FDA group in Washington,…
FDA Tells How to Tweet About Prescription Drugs and Devices
The USFDA has published draft guidance (scroll down to read the draft) telling Pharma companies how to tweet about their…
FDA Inquiring: Unreported Injuries Due to Robotic Surgeries
In 2012, the FDA received detrimental reports of injuries, death and malfunctions associated with robotic surgery procedures…
FDA Ignores Medical Board and Approves Painkiller with Potential of Abuse
The FDA has totally ignored the 11-2 disapproval of its medical advisory board and proceeded to approve Zohydro, a drug,…
How Many Rodent Hairs Allowed in Your Paprika by the FDA?
The recently published Defect Levels Handbook by the FDA enumerates the levels of defect beyond which it becomes actionable.…
FDA Gives First Approval to Pre-Surgical Breast Cancer Drug
On Monday, the FDA gave its first approval to a pre-surgical breast cancer drug. The drug, Perjeta, manufactured by Roche…
Botox Finds FDA Approval for Treating Crows Feet
On Wednesday, the FDA announced its approval for using Botox as a cosmetic for treating the wrinkles around eyes, that…
FDA Seeks Input of the Public on Menthol Cigarettes
On Tuesday, the FDA put out a notice seeking public input on menthol cigarettes. The announcement mentioned, “Despite decades of…
FDA Gives Go Ahead to Brain Wave Test for Assessing ADHD in Children
On Monday, the U.S. Food and Drug Administration (FDA) announced that it has approved the first brain wave test that…
FDA Changing Labeling Rules for Tobacco Alternatives
On Monday, the Consumer Updates of the U.S. Food and Drug Administration informed that the labels of nicotine replacement therapy…