Guideline Central Blog

Monthly Alerts

Upcoming FDA Approvals & Decisions - December 2024

Upcoming FDA Decisions – December 2024

The Food and Drug Administration (FDA) protects public health by guaranteeing the safety, effectiveness, and security of pharmaceuticals and medical devices. The Prescription Drug User Fee Act (PDUFA) date marks the deadline by which the FDA must complete its review of drug applications. Occasionally, an advisory committee (AdCom) meeting is convened to assess the drug […]

Upcoming FDA Approvals & Decisions

Upcoming FDA Decisions – November 2024

The Food and Drug Administration (FDA) protects public health by guaranteeing the safety, effectiveness, and security of pharmaceuticals and medical devices. The Prescription Drug User Fee Act (PDUFA) date marks the deadline by which the FDA must complete its review of drug applications. Occasionally, an advisory committee (AdCom) meeting is convened to assess the drug […]

Upcoming FDA Approvals & Decisions

Upcoming FDA Decisions – October 2024

The Food and Drug Administration (FDA) protects public health by guaranteeing the safety, effectiveness, and security of pharmaceuticals and medical devices. The Prescription Drug User Fee Act (PDUFA) date marks the deadline by which the FDA must complete its review of drug applications. Occasionally, an advisory committee (AdCom) meeting is convened to assess the drug […]

Upcoming FDA Approvals & Decisions - September 2024

Upcoming FDA Decisions – September 2024

The Food and Drug Administration (FDA) protects public health by guaranteeing the safety, effectiveness, and security of pharmaceuticals and medical devices. The Prescription Drug User Fee Act (PDUFA) date marks the deadline by which the FDA must complete its review of drug applications. Occasionally, an advisory committee (AdCom) meeting is convened to assess the drug […]

Upcoming FDA Approvals & Decisions

Upcoming FDA Decisions – August 2024

The Food and Drug Administration (FDA) protects public health by guaranteeing the safety, effectiveness, and security of pharmaceuticals and medical devices. The Prescription Drug User Fee Act (PDUFA) date marks the deadline by which the FDA must complete its review of drug applications. Occasionally, an advisory committee (AdCom) meeting is convened to assess the drug […]

Upcoming FDA Approvals & Decisions - July 2024

Upcoming FDA Decisions – July 2024

The Food and Drug Administration (FDA) protects public health by guaranteeing the safety, effectiveness, and security of pharmaceuticals and medical devices. The Prescription Drug User Fee Act (PDUFA) date marks the deadline by which the FDA must complete its review of drug applications. Occasionally, an advisory committee (AdCom) meeting is convened to assess the drug […]

FDA Approvals - May 2024

Guideline Med Alerts & FDA Approvals – May 2024

Breyanzi (Bristol Myers Squibb)Expanded Indication Retevmo (Eli Lilly) Expanded Indication Onyda XR (Tris Pharma)  Bkemv (Amgen)Biosimilar to Soliris Opuviz (Biogen) Biosimilar to Eylea Yesafili (Biocon Biologics) Biosimilar to Eylea Imdelltra (Amgen)  Clinolipid (Baxter) Expanded Indication ColoSense (Geneoscopy) New Formulation Myhibbin (Azurity Pharmaceuticals) New Formulation Cyltezo (Boehringer Ingelheim) New Formulation Sign up for alerts and stay informed on […]

Upcoming FDA Approvals & Decisions - June 2024

Upcoming FDA Decisions – June 2024

The Food and Drug Administration (FDA) protects public health by guaranteeing the safety, effectiveness, and security of pharmaceuticals and medical devices. The Prescription Drug User Fee Act (PDUFA) date marks the deadline by which the FDA must complete its review of drug applications. Occasionally, an advisory committee (AdCom) meeting is convened to assess the drug […]

Upcoming FDA Decisions – May 2024

The Food and Drug Administration (FDA) protects public health by guaranteeing the safety, effectiveness, and security of pharmaceuticals and medical devices. The Prescription Drug User Fee Act (PDUFA) date marks the deadline by which the FDA must complete its review of drug or device applications. Below, you will find a list of drugs and devices, […]