Generic Drugs Undergo Rigorous FDA Review
Maybe you’ve had this experience: You go to fill a prescription, and the pharmacist mentions there is a generic available. You’ve noticed generic drugs often cost less and wonder: How can I be sure they are as safe and effective as brand name drugs?
Applying the rigorous standards set out by law, the U.S. Food and Drug Administration ensures that generic drugs are as safe and effective as the brand name drug products they copy. Today, about 9 in 10 prescriptions filled in the U.S. are for generic drugs.
Hearing Aids and Personal Sound Amplification Products: What to Know
Are you or a loved one having a hard time hearing? Perhaps you considered getting a hearing aid in the past?
Hearing aid technology keeps evolving, which means there’s a growing variety of styles and features to consider.
“People who already use a hearing aid know that selecting one is not a simple decision,” says Eric Mann, M.D., Ph.D., Senior Advisor in the U.S. Food and Drug Administration office responsible for hearing aids. “Hearing loss affects people in different ways. So, it’s important to choose a hearing aid that’s appropriate for your condition and fits your lifestyle.”
Tips to Stay Safe in the Sun: From Sunscreen to Sunglasses
Sun safety is always in season. It’s important to protect your skin from sun damage throughout the year, no matter the weather. Why? Sun exposure can cause sunburn, skin aging (such as skin spots, wrinkles, or “leathery skin”), eye damage, and skin cancer, the most common form of cancer in the U.S.
Skin cancer is on the rise in the U.S. The National Cancer Institute estimates there will be 99,780 new cases of skin melanomas and 7,650 related deaths in 2022. In 2019, there were an estimated 1.3 million people living with melanoma of the skin in the U.S. About 4.3 million people are treated for basal cell carcinoma and squamous cell carcinoma, two of the most common types of skin cancer, in the U.S. every year, according to published data from the Centers for Disease Control and Prevention.
Plan, Prepare and Protect Your Pet Before, During and After an Emergency
They make us laugh. They are usually waiting for us when we get home from work and school. They give us unconditional love. They are often our best friends. And they depend on us for everything: food, water, healthcare. They are our pets and part of the family.
Our pets also depend on us when emergency strikes. Are you ready with your pet preparedness plan?
Replacement Reagent and Instrument Family Policy for In Vitro Diagnostic Devices
In 2003, FDA issued an updated guidance on the "Replacement Reagent and Instrument Family Policy" for in vitro diagnostic (IVD) devices. The 2003 guidance described a mechanism for manufacturers to follow when applying an assay that was previously cleared based on performance characteristics when used with a specified instrument to an additional instrument that is either cleared or a member of an instrument family from which another instrument was previously cleared.
Hydrogen Peroxide-Based Contact Lens Care Products: Consumer Labeling Recommendations - Premarket Notification (510(k)) Submissions
FDA is issuing this draft guidance to provide labeling recommendations for hydrogen peroxide-based contact lens care products (HPCPs) submitted in premarket notification (510(k)) submissions. These labeling recommendations are important because misuse associated with these devices has resulted in serious eye injuries. FDA believes that the labeling recommendations in this guidance may help manufacturers develop labeling with information about specific risks and directions for use of the HPCPs in conjunction with a user’s prescribed contact lenses.
FDA Regional Implementation Guide for E2B(R3) Electronic Transmission of Individual Case Safety Reports for Drug and Biological Products
This technical specifications document is to assist interested parties in electronically submitting individual case safety reports (ICSRs) (and ICSR attachments) to the Center for Drug Evaluation and Research (CDER) and the Center for Biologics Evaluation and Research (CBER) in the FDA (or Agency).
Webinars and Virtual Workshops
Virtual Stakeholder Webinar: Accelerating Access to Critical Therapies for ALS Act
August 24, 2022; 3:00 PM - 4:00 PM ET
On June 23, 2022, the FDA unveiled its Action Plan for Rare Neurodegenerative Diseases including Amyotrophic Lateral Sclerosis (ALS) – a five-year strategy for improving and extending the lives of people living with rare neurodegenerative diseases by advancing the development of safe and effective medical products and facilitating patient access to novel treatments.
Drug Development Considerations for the Prevention of Healthcare-Associated Infections
August 30, 2022; 8:30 AM - 5:00 PM ET
The Centers for Disease Control and Prevention (CDC) and FDA are co-sponsoring this public virtual workshop.
Discussions are planned around the following topics/areas:
- The current state of development of pathogen-directed products used to prevent healthcare-associated infections
- Evidence supporting decolonization and pathogen reduction (in colonized patients) as a strategy to prevent infection and transmission of antimicrobial-resistant healthcare-associated pathogens
- Antimicrobial resistance threats as potential targets for decolonization and pathogen reduction
- Challenges and potential approaches to drug development and registration of products for the prevention of healthcare-associated infections
Compounding Quality Center of Excellence Annual Conference
September 6 - 8, 2022
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The conference will highlight how stakeholders can protect patients from unsafe, ineffective, and poor-quality compounded drugs while preserving access to compounded drugs for patients who have a medical need for them.
The conference will feature subject matter expert presentations, interactive sessions, and roundtable conversations. Stakeholders in the compounding community will share their perspectives. Attendees will be able to engage with FDA, learn about emerging trends, and gain quality compounding insights.
2022 Scientific Computing Days
September 7 - 8, 2022; - ET
The FDA Scientific Computing Board is a group of scientists and IT specialists at FDA who advocate for scientific computing needs, and requirements to advance FDA’s scientific and regulatory mission. The 10th annual Scientific Computing Days symposium is a conference promoting the latest advances in scientific computing technologies. This year’s theme is “Scientific Computing: In the Field, Around the World, and On the Edge.” The event’s goal is to help FDA improve the application of technology and scientific computing in support of the FDA’s public health mission.
Reporting Drug Amount Under Section 510(j)(3) of the FD&C Act
September 8, 2022; 9:30 AM - 3:30 PM ET
In 2020, the Coronavirus Aid, Relief, and Economic Security Act (CARES Act) amended the FD&C Act to require that each person (including repackers and labelers) who registers with FDA under section 510 of the FD&C Act with regard to a human or animal drug must report annually to FDA the amount of each listed drug that was manufactured, prepared, propagated, compounded, or processed by such person for commercial distribution.
In this webinar, FDA will provide an overview of the drug amount reporting program, including discussions of how FDA uses the drug amount report data and who reports and how (with examples and demonstrations).
The Stakeholder Engagement Staff resides within the Office of the Commissioner and falls under the Office of External Affairs. We aim to build stronger relationships with health professional organizations, consumer groups, trade associations, patient advocacy organizations, think tanks/academia, and other stakeholders, in order to better inform our policy making process, identify policy hurdles or stakeholder misconceptions, and create strategic collaborations.