Updates FDA Voices Innovation and Scientific Collaboration Moved the Generic Drug Program Forward In 2021  By: Sally Choe, Ph.D., Director, Office of Generic Drugs, Center for Drug Evaluation and Research (pictured below)  Providing patients and consumers greater access to safe and effective medicines is a public health priority for the U.S. Food and Drug Administration. The FDA's Office of Generic Drugs (OGD) has a mission to help ensure high-quality, affordable generic drugs are readily available. Currently 90% of all prescriptions dispensed in the U.S. are for generic drugs. To support the availability of generic drugs, the generic drug program approves safe, effective, high-quality drugs and monitors those drugs once they are on the market. | ICYMI! Dr. Robert Califf return as FDA's Commissioner  "It is my great honor to have the opportunity to return to the FDA in the position of Commissioner. I thank President Biden for having the confidence to nominate me to lead this essential agency at such a critical time. And I want to thank the Senate for confirming me after a thorough vetting. I am grateful to the many people at the FDA, HHS, and the White House who spent countless hours getting me through the exhaustive process. I especially want to recognize & thank Dr. Janet Woodcock, who has so ably filled the position of Acting Commissioner for more than a year. I can't think of anyone who more capably could have handled the unprecedented challenges & extraordinary pressures that come with this position. I am grateful that Dr. Woodcock has agreed to stay on in the position of Principal Deputy Commissioner, and I look forward to her support and advice, particularly during this critical transition period. We face enormous challenges as a nation and as an agency, and with her support and the many old and new friends at the agency, I look forward to being able to hit the ground running. I promise each member of the FDA team and the American people my commitment to doing the best I can, relying on the integrity of science and the FDA's continued application of science in meeting our awe-inspiring responsibilities," said FDA's Commissioner, Dr. Robert Califf. Follow along with the Commissioner's Twitter page here! Tianeptine Products Linked to Serious Harm, Overdoses, Death  People seeking to treat their ailments sometimes mistake a product as being safe because it's easily available, whether online or even at gas stations. But availability is no indication of effectiveness or safety. This is especially true of tianeptine, an unapproved drug associated with serious health risks and even death. Tianeptine is not approved by the U.S. Food and Drug Administration for any medical use. Despite that, some companies are illegally marketing and selling products containing tianeptine to consumers. They are also making dangerous and unproven claims that tianeptine can improve brain function and treat anxiety, depression, pain, opioid use disorder, and other conditions. Although the FDA has warned consumers about tianeptine, vendors continue to market and sell this drug. The FDA is aware that tianeptine has been sold online, typically in tablet or powder form. Webinars and Virtual Workshops 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. Webinar - Principles for Selecting, Developing, Modifying, and Adapting Patient-Reported Outcome Instruments for Use in Medical Device Evaluation - Final Guidance March 1, 2022; 1:00 PM - 2:30 PM ET The U.S. Food and Drug Administration (FDA) will host a webinar for industry and other interested stakeholders to discuss and answer questions about the final guidance: Principles for Selecting, Developing, Modifying and Adapting Patient-Reported Outcome Instruments for Use in Medical Device Evaluation. This guidance outlines recommended best practices to help ensure relevant, reliable, and sufficiently robust patient-reported outcome instruments are developed, modified, or adapted using the least burdensome approach. Registration is not required. Public Meeting: FDA Rare Disease Day 2022 March 4, 2022; 9:00 AM - 4:30 PM ET  The theme for FDA's Rare Disease Day is "Sharing Experiences in Rare Diseases Together." Patients, patient advocates, researchers and medical product developers may benefit from attending this public meeting on rare disease product development. During presentations and panel discussions various stakeholders will share their perspectives on and experiences in rare disease product development. FDA, MHRA, and Health Canada Good Clinical Practice Workshop: Global Clinical Trials - Considerations and Lessons Learned from the Changing Landscape (2022) March 7 - 9, 2022; 7:30 AM - 12:00 PM ET FDA, the Medicines and Healthcare products Regulatory Agency (MHRA), and Health Canada will provide attendees with insight into key topics, compliance trends and the opportunity to hear first-hand from regulators about lessons learned from the changing clinical trial landscape. Race & Genetic Ancestry in Medicine. A Time for Reckoning Racism March 8, 2022; 3:00 PM - 4:00 PM ET About the Presentation
In the context of the national debate over the use of race/ethnicity in clinical medicine and biomedical research, some have recommended a race/ethnicity-blind approach to medicine. This recommendation is based on the premise that race and ethnicity, as social constructs, have no utility in medicine for clinical decisions and its use perpetuates racism and health inequities. Registration is not required. RegenMedEd Webinar: The Critical Role of Patients in Advancing Gene Therapy Treatments for Rare Diseases March 9, 2022; 11:00 AM - 12:00 PM ET  This webinar will bring together patients, caregivers, advocates, and other important stakeholders to celebrate and recognize the contributions that patients with rare diseases have made to advancements in regenerative medicine. Conversations on Cancer: "More Isn't Always Better: Understanding Cancer Treatment Tolerability" March 10, 2022; 2:00 PM - 3:30 PM ET This panel discussion will feature a diverse group of speakers, including patients, clinicians, researchers, and FDA representatives to share their unique perspectives. The speakers will discuss the importance and integration of the patient experience in evaluating tolerability (for example, through use of patient-reported outcome measures), clinician consideration of patient-reported tolerability, the impact of tolerability on treatment decisions, and dose optimization. Public Meeting: Final Assessment of the Program for Enhanced Review Transparency and Communication in the Biosimilar User Fee Act March 22, 2022; 9:30 AM - 12:30 PM ET As part of the Biosimilar User Fee Act (BsUFA) for fiscal years (FYs) 2018 through 2022, FDA committed to contracting with an independent third party to conduct interim and final assessments of the Program for Enhanced Review Transparency and Communication ("the Program") for 351(k) Biologics License Applications (BLAs). The purpose of the assessments is to determine the extent to which the Program improves the efficiency and effectiveness of 351(k) BLA reviews. 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. Did someone forward you this email? Sign up below! | 
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