Trump Government Reorg Proposes Overhaul of FDA, NIH

Trump Government Reorg Proposes Overhaul of FDA, NIH

The Trump Administration is proposing a massive overhaul of the federal government that includes a restructuring of the National Institutes of Health (NIH) and the Food and Drug Administration (FDA), as well as a reduction in the size of the US Public Health Service Commissioned Corps. Under the plan, announced on June 20, the administration […]

The FDA May Approve Its First Cannabis-Based Drug This Week

The FDA May Approve Its First Cannabis-Based Drug This Week

The Federal Drug Administration is set to decide the status of a cannabis-based drug by Wednesday. If approved, Epidiolex, developed by the British GW Pharmaceuticals, will be the first drug directly derived from marijuana to earn FDA approval. Although several states have legalized the medical and recreational use of marijuana, the federal administration has yet […]

FDA Action Alert: It's a Big Week

FDA Action Alert: It's a Big Week

It’s a big week for the U.S. Food and Drug Administration (FDA) with plenty of upcoming decisions. Achaogen’s plazomicin, an antibiotic for multi-drug resistant (MDR) gram-negative infections has a PDUFA date of Monday, June 25. The agency accepted the NDA for review on January 2, and granted it Priority Review. The drug is up for […]

First marijuana-derived drug is on the verge of FDA approval

First marijuana-derived drug is on the verge of FDA approval

At 3 months old, Marissa Parsons began having frequent seizures, some lasting a half-hour. For almost two decades, her desperate parents tried drug after drug to treat her rare type of childhood epilepsy, but the medications mostly produced side effects — pancreatitis, hives and extreme drowsiness — and she was frequently hospitalized. Family outings became […]

First marijuana-derived drug is on the verge of approval

First marijuana-derived drug is on the verge of approval

Marissa Parsons and her family visit the Grand Canyon in 2016. (Ronda Parsons) At 3 months old, Marissa Parsons began having frequent seizures, some lasting a half-hour. For almost two decades, her desperate parents tried drug after drug to treat her rare type of childhood epilepsy, but the medications mostly produced side effects — pancreatitis, […]

White House proposes a reduction of the FDA's mission

White House proposes a reduction of the FDA's mission

WASHINGTON — The Trump administration has proposed a fundamental change to the mission of the Food and Drug Administration, one that would transfer most of the responsibility for regulating food safety to the Department of Agriculture and rename the FDA the “Federal Drug Administration.” The proposal is part of a wide-reaching plan that was released […]

FDA Grants Necrobiosis Lipoidica Orphan Drug Designation

FDA Grants Necrobiosis Lipoidica Orphan Drug Designation

The US Food and Drug Administration (FDA) has granted Orphan Drug Designation to Processa Pharmaceuticals, Inc. for the company’s clinical compound PCS499 for the treatment of Necrobiosis lipoidica (NL). Processa Pharmaceuticals intends to begin clinical studies of PCS499 this year. “We are very pleased that PCS499 has received Orphan Drug Designation from FDA for the […]

FDA, Drugmakers Continue Work to End Critical Drug Shortages

FDA, Drugmakers Continue Work to End Critical Drug Shortages

The US Food and Drug Administration (FDA) this week issued a statement about its efforts to address shortages of intravenous fluids, injectable opioids, and EpiPen epinephrine shots (Mylan). The agency said it has expedited reviews of applications from makers of saline to try to add capacity and additional supply. The FDA said it is also […]