Updates
FDA Voices
What FDA’s Foods Program Achieved in 2021 to Protect Consumers and the Food Supply
 By: Frank Yiannas, Deputy Commissioner for Food Policy and Response
Despite the unprecedented challenges we’ve all faced during the COVID-19 pandemic, 2021 was another important year for the U.S. Food and Drug Administration’s Foods Program.
I’d like to highlight some of the strides we made last year in protecting the safety of human foods, which we will continue building on this year. They reflect on the work done by the dedicated teams in the FDA’s Office of Food Policy and Response, the Center for Food Safety and Applied Nutrition, and the Office of Regulatory Affairs.
Many Important Drugs Approved in 2021 as COVID-19 Pandemic Continues
 By: Patrizia Cavazzoni, M.D., Director, Center for Drug Evaluation and Research
The U.S. Food and Drug Administration’s Center for Drug Evaluation and Research (CDER) approved a wide variety of safe and effective new drug therapies in 2021 despite challenges brought on by the ongoing COVID-19 pandemic. These new approvals, spanning a wide range of diseases and conditions, aim to help many patients live better and potentially longer lives.
Innovation Across Medical Conditions
In 2021, we approved 50 new drugs never before approved or marketed in the U.S., known as “novel” drugs. We also approved drugs in new capacities, such as for new uses and patient populations.
ICYMI!
Know Your Treatment Options for COVID-19
 Patients today have more treatment options in the battle against coronavirus disease. The U.S. Food and Drug Administration has approved one drug treatment for COVID-19 and has authorized others for emergency use during this public health emergency. In addition, many more therapies are being tested in clinical trials to evaluate whether they are safe and effective in combating COVID-19.
Here’s a closer look at some of the available COVID-19 treatments and how to get more information about them and others. Talk to your health care provider about available treatment options if you have COVID-19. Your provider will know the best option for you, based on your symptoms, risks, and health history.
Webinars and Virtual Workshops
Endpoint Considerations to Facilitate Drug Development for Niemann-Pick Type C (NPC) Public Workshop
January 24 - 25, 2022; 12:00 PM - 3:30 PM ET
The FDA and Duke-Margolis will host a virtual public workshop on endpoint considerations to facilitate drug development for NPC. During this workshop, participants will discuss clinical endpoints relevant to NPC clinical trials and innovative strategies to support therapeutic development for patients with NPC.
The workshop is open to the public and will include representation from the patient community, health care providers, industry, and other federal partners.
CDER BIMO GCP Compliance and Enforcement
February 16, 2022; 1:00 PM - 3:30 PM ET
This webinar will:
- Provide a general overview of the Bioresearch Monitoring (BIMO) program
- Discuss Good Clinical Practice (GCP) inspectional processes, compliance evaluation and enforcement, including case examples
- Summarize findings from a recent publication on follow-up inspectional activities after FDA notifies an inspected entity of serious-noncompliance
- Include live Q&A session and a moderated panel discussion
Webinar on Draft Guidances on Transition Plans for COVID-19 Related Medical Devices
February 22, 2022; 1:00 PM - 2:30 PM ET
The U.S. Food and Drug Administration (FDA) will host a webinar for stakeholders interested in learning more about the draft guidances on COVID-19 transition plans for medical devices. This webinar will:
- Help prepare manufacturers and other stakeholders for the orderly and transparent transition to normal operations
- Describe recommendations regarding submitting a marketing submission and the timeline for doing so
- Provide examples to illustrate the transition policies and exemplify the 180-day transition period timeline
- Answer your questions about the draft guidances on COVID-19 transition plans
Registration is not required.
Bioequivalence Studies with Pharmacokinetic Endpoints for Drugs Submitted Under an ANDA
February 24, 2022; 1:00 PM - 3:00 PM ET
In August 2021, FDA revised the draft guidance for industry on Bioequivalence (BE) Studies with Pharmacokinetic Endpoints for Drugs Submitted Under an ANDA to update and clarify the agency’s recommendations regarding BE information submitted in an Abbreviated New Drug Application (ANDA) submission, provide assistance to potential ANDA applicants, and support access for patients to lower cost, high quality medicines.
This webinar will take a deeper look at the revised draft guidance, describe major changes from the previous draft guidance published in 2013, and provide clarification to comments received through the public docket. For example, we received questions on study population (with regard to sex and age), and bioequivalence assessment for.
About Us
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.
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