- November 17, 2022 - Update: Certain Philips Respironics Ventilators, BiPAP Machines, and CPAP Machines Recalled Due to Potential Health Risks
- - FDA Spurs Innovation for Human Food from Animal Cell Culture Technology
How AEDs in Public Places Can Restart Hearts
Sudden cardiac arrest occurs when the heart suddenly and unexpectedly stops pumping blood. It can happen to anyone, at any time, and signs include sudden collapse and immediate loss of consciousness.
Unlike heart attacks, which are caused by a blockage in an artery to the heart, sudden cardiac arrest is caused when the heart’s electrical system malfunctions. This produces abnormal heart rhythms, called arrhythmias, that make the heart unable to pump blood.
If cardiac arrest does occur, rapid treatment with a medical device called an automated external defibrillator (AED) can be lifesaving.
How to Buy Medicines Safely From an Online Pharmacy
Have you ever been tempted to buy your medicines from an online pharmacy or another website?
You can protect yourself and your family by being cautious when buying medicine online. Some pharmacy websites operate legally and offer convenience, privacy, cost savings and safeguards for purchasing medicines.
Not all websites are the same. The FDA warns that there are many unsafe online pharmacies that claim to sell prescription drugs at deeply discounted prices, often without requiring a prescription. These internet-based pharmacies often sell unapproved, counterfeit or otherwise unsafe medicines outside the safeguards followed by licensed pharmacies.
FDA’s Cybersecurity Modernization Action Plan
By: Vid Desai, Chief Information Officer (pictured below) and Craig Taylor, Chief Information Security Officer
The FDA is critical to protecting and promoting public health. The products the FDA regulates are in every supermarket, pharmacy, and home across the U.S. Cybersecurity touches every facet of the FDA’s broad, complex responsibility. It’s one of our agency’s top priorities, and we take it seriously, particularly given today’s increased cybersecurity risks.
During the pandemic, the FDA experienced a 457% increase in reconnaissance activities, denial of service, attempted exploitation, and other cyber incidents against IT infrastructure, that includes nearly 9.5 billion firewall and intrusion detection blocks on a monthly basis.
Focusing on Prevention to Safeguard Infant Formula
By: Susan T. Mayne, Ph.D., Director, Center for Food Safety and Nutrition (pictured below)
Over this last year, some families around our country faced challenges finding infant formula, a product that serves as the sole source of nutrition for many infants in the U.S. What started with reports of illnesses in infants led to a for-cause inspection of a major formula manufacturing facility.
Environmental sampling in that facility by the FDA identified multiple strains of Cronobacter sakazakii, a potentially harmful bacteria to infants, and other insanitary conditions that prompted a large-scale voluntary recall and pause in production to safeguard public health. These actions further stressed the infant formula supply chain already strained by the COVID-19 pandemic, creating hardships for parents and caregivers who rely on these products to feed their babies and loved ones.
Recently, the FDA released an Evaluation of the Agency’s Infant Formula Response, which notes various opportunities for improvement, but at the heart of this particular issue is safety.
FDA Approves Second Interchangeable Insulin Product, Rezvoglar
The FDA approved the second interchangeable biosimilar insulin product to Lantus (insulin glargine), Eli Lilly’s Rezvoglar (insulin glargine-aglr).
Rezvoglar is a long-acting human insulin analog indicated to improve glycemic control in adults and pediatric patients with diabetes mellitus.
FDA previously approved Rezvoglar as a biosimilar to Lantus on December 17, 2021. A biosimilar is a biological product (biologic) that is highly similar to and has no clinically meaningful differences from an existing FDA-approved biologic, called a reference product.
An interchangeable biosimilar is a biosimilar that meets additional requirements and may be substituted for the reference product at the pharmacy, depending on state pharmacy laws, similar to how generic drugs are substituted. A company has to specifically apply for interchangeability.
For more information about biosimilar products, visit the link below.
Webinars and Virtual Workshops
Drug Master File (DMF) Workshop: GDUFA III Enhancements and Structured Data Submissions
November 30, 2022; 8:00 AM - 4:30 PM ET
This conference is designed to cover two topics. First is to discuss the two Drug Master File (DMF) enhancements specified under the Generic Drug User Fee Amendments (GDUFA) III Commitment Letter which includes DMF review prior to ANDA submission and assessment of solicited DMF amendments outside of an application. Second is an update on the future state of DMF submissions and assessments including discussion of Knowledge-Aided Assessment and Structured Application (KASA), Structure-Data (SD) files and Global Substance Registration Systems (GSRS) database.
2022 FDA Digital Transformation Symposium
December 5 - 7, 2022
Day 1: - ET
Day 2: - ET
Day 3: 8- ET
About the Symposium:
Learn more about the FDA’s IT vision and strategic direction.
Hear from FDA leaders on how the agency is leveraging advances in data, cloud, user experience (UX), cybersecurity, IT governance, and operational/organizational excellence to deliver on its mission to protect public health.
Participate and engage in information sharing with industry, tech, and vendor communities on how the FDA can continue to collaborate with stakeholder constituents to drive innovation, key initiatives, and achieve successful technology solutions.
Excipients and Formulation Assessments of Complex Generic Products: Best Practices and Lessons Learned Webinar
December 6, 2022; 8:00 AM - 5:00 PM ET
The goal of this webinar is to provide an overview of the regulatory framework, scientific concepts, product-specific challenges, and best practices related to development of complex generic drug products that are either required or recommended to have the same formulation as their respective RLDs.
The one-day webinar will include five sessions composed of presentations from FDA and the pharmaceutical industry followed by panel discussions to answer attendee questions.
FDA Broad Agency Announcement Day 2022
December 6, 2022; 10:00 AM - 3:30 PM ET
FDA funds extramural research through an agency-wide Broad Agency Announcement (BAA) for research and development to support regulatory science and innovation. FDA solicits for advanced research and development proposals to support regulatory science and innovation. FDA anticipates that research and development activities awarded under this BAA will serve to advance scientific knowledge to accomplish its mission to protect and promote the health of our nation.
View Upcoming FDA Meetings, Conferences and Workshops
Public meetings involving the FDA: Upcoming events, past meetings, meeting materials, and transcripts
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.