FDA to Communicate Safety Monitoring Activities to Consumers and Health Care Professionals

The U.S. Food and Drug AdministrationThe U.S. Food and Drug Administration unveiled a new source of information for patients and health care professionals on the safety of recently approved drugs and biologics.

Summaries of FDA safety analyses on recently approved products will now be periodically prepared and posted on FDA's website along with a brief discussion of the steps FDA is taking to address any identified safety issues.

Some side effects may not become apparent until after a medicine has been approved and becomes available to a larger, more diverse population than the patients who participated in clinical trials that supported approval. The new summaries provide a comprehensive look at safety data early in the product's post-approval life cycle and are based on reports by manufacturers, providers, consumers and others to the FDA's Adverse Event Reporting System (AERS) and the Vaccine Adverse Event Reporting System maintained by the FDA and the Center for Disease Control and Prevention; periodic safety information submitted to FDA by manufacturers; information contained in the medical literature; and data from ongoing drug and biologic studies.

Included in the summaries may be information on potentially serious, previously unidentified risks, if any are found during the review, as well as known adverse events that occur more often than they did during clinical studies. The summaries will also include a brief discussion of any steps FDA may be taking to address these safety issues.

Under Section 915 of the Food and Drug Administration Amendments Act of 2007 (FDAAA), FDA is required to prepare the safety summaries within 18 months after a product's approval or after it has been used by 10,000 patients, whichever comes later.

"Conducting systematic, comprehensive, safety reviews of recently approved drugs and biologics provides an early detection mechanism for potentially serious risks and complements the FDA's analysis of safety data during drug development and the agency's routine monitoring of safety information after product approval," said Gerald Dal Pan, M.D., M.H.S., director of the Office of Surveillance and Epidemiology in the FDA's Center for Drug Evaluation and Research.

"These summaries will provide clear and useful information in a timely manner that can be used by providers and patients to make informed decisions about an individual's health," said Robert Ball, M.D., M.P.H., Sc.M., director of the Office of Biostatistics and Epidemiology in the Center for Biologics Evaluation and Research.

Initial summary reports will contain information on drugs and biologics approved since September 2007, including several drugs for infections, hypertension, depression and other conditions. The summary reports will be located on an FDA Web page that was first established in 2008 to serve as a portal for drug safety information.

For more information:

Most Popular Now

AstraZeneca enters license agreement with KYM Bios…

AstraZeneca and KYM Biosciences Inc.* have entered into a global exclusive licence agreement for CMG901, a potential first-in-class antibody drug conjugate (ADC) targetin...

Pfizer receives positive FDA Advisory Committee vo…

Pfizer Inc. (NYSE: PFE) announced that the U.S. Food and Drug Administration's (FDA) Vaccines and Related Biological Products Advisory Committee (VRBPAC) voted that avail...

First nasal monoclonal antibody treatment for COVI…

A pilot trial by investigators from Brigham and Women's Hospital, a founding member of the Mass General Brigham healthcare system, tested the nasal administration of the ...

US FDA Advisory Committee votes to support effecti…

GSK plc (LSE/NYSE: GSK) announced that the US Food and Drug Administration (FDA) Vaccines and Related Biological Products Advisory Committee (VRBPAC) voted that the avail...

"Semantic similarity" leads to novel dru…

The words that researchers use to describe their results can be harnessed to discover potential new treatments for Parkinson's disease, according to a new study published...

Tumour cells' response to chemotherapy is driven b…

Cancer cells have an innate randomness in their ability to respond to chemotherapy, which is another tool in their arsenal of resisting treatment, new research led by the...

Engineered bacteria find tumors, then alert the au…

Combining discoveries in cancer immunology with sophisticated genetic engineering, Columbia University researchers have created a sort of "bacterial suicide squad" that ...

Nanosatellite shows the way to RNA medicine of the…

The RNA molecule is commonly recognized as messenger between DNA and protein, but it can also be folded into intricate molecular machines. An example of a naturally occur...

Gene and cell therapies to combat pancreatic cance…

Pancreatic cancer is an incurable form of cancer, and gene therapies are currently in clinical testing to treat this deadly disease. A comprehensive review of the gene an...

Digital twin opens way to effective treatment of i…

Inflammatory diseases like rheumatoid arthritis have complex disease mechanisms that can differ from patient to patient with the same diagnosis. This means that currently...

Pfizer's ZAVZPRET™ (zavegepant) migraine nasal spr…

Pfizer Inc. (NYSE: PFE) today announced the U.S. Food and Drug Administration (FDA) has approved ZAVZPRET™ (zavegepant), the first and only calcitonin gene-related peptid...

AI conjures proteins that speed up chemical reacti…

For the first time, scientists have used machine learning to create brand-new enzymes, which are proteins that accelerate chemical reactions. This is an important step in...