Updates Consumer Updates Learn More About COVID-19 Vaccines From the FDA  The U.S. Food and Drug Administration approved Comirnaty for the prevention of COVID-19 caused by SARS-CoV-2 in individuals 16 years of age and older. Help Stop the Spread of Coronavirus and Protect Your Family  The COVID-19 pandemic demands that we remain vigilant in our daily lives as we return to everyday activities. We can each take some simple steps to protect ourselves, our families, and our communities. Beware of Fraudulent Coronavirus Tests, Vaccines and Treatments  While we remain vigilant to protect our families and communities from COVID-19, some people might be tempted to buy or use questionable products that claim to help diagnose, treat, cure, and even prevent coronavirus disease. Vaccination is one of the best ways to protect everyone who is eligible from COVID-19. The U.S. Food and Drug Administration has approved Comirnaty for the prevention of COVID-19 in people ages 16 and older. The FDA-approved Comirnaty (COVID-19 Vaccine, mRNA) and the two emergency use authorization (EUA) formulations of Pfizer-BioNTech COVID-19 Vaccine for ages 12 years and older, when prepared according to their respective instructions for use, can be used interchangeably without presenting any safety or effectiveness concerns. FDA Pharmacists Help You Use Medicines Safely  How often has this happened to you: You pick up a prescription at the pharmacy and later realize you have questions about something in the directions or warnings. Or you buy an over-the-counter (OTC) drug but aren't sure about the correct dosage after reading the label. That's where pharmacists come in. Whether at your local pharmacy or the U.S. Food and Drug Administration, pharmacists help patients achieve the best possible outcome when taking drugs. Vaccines Protect Children From Harmful Infectious Diseases  Vaccines are essential to getting children off to a healthy start in life. Because immunization programs of the 20th and 21st century have been so successful, many parents today have never seen the many vaccine-preventable diseases that were once common. They don't realize that those infectious diseases could reemerge. If individuals choose not to vaccinate themselves or their children, some diseases that are now rare or nonexistent in the United States may resurface. What to Know About Breast Implants  Should I get breast implants? Should they be saline or silicone? Which style? How much monitoring is needed after surgery? Those are common questions people have when considering breast implants. That's why the FDA offers the following information to help people make informed decisions about whether or not to use breast implants. The FDA has approved implants for increasing breast size, for reconstruction after breast cancer surgery or trauma, and to correct developmental defects. The FDA has also approved breast implants to correct or improve the result of a previous surgery. Your Animal Is Sick. Was It Something They Ate? Vet-LIRN May Be Able to Help  Your family's beloved pet has gotten sick, and you and your veterinarian are working together to find the cause. While there are many potential causes, one possibility you may discuss with your veterinarian is whether the illness could be linked to your pet's food. Vet-LIRN (Veterinary Laboratory Investigation and Response Network), a program from the U.S. Food and Drug Administration's (FDA) Center for Veterinary Medicine (CVM), is a network that connects laboratories around the country looking for clues that might solve animal illness mysteries related to animal foods or animal drugs. Vet-LIRN allows the FDA to partner with state and university Diagnostic Laboratories. ICYMI! FDA's Advanced Manufacturing Initiatives Helping to Provide Quality Human Drugs for Patients  By: Michael Kopcha, PhD, RPh, Director of the Office of Pharmaceutical Quality (OPQ), Center for Drug Evaluation and Research (CDER) and Patrizia Cavazzoni, MD, Director of CDER Patients with diseases including cystic fibrosis, HIV, breast cancer, leukemia, and asthma are benefitting from medications manufactured in newer, more expedient, and more flexible ways. This is because certain drug manufacturers have adopted advanced manufacturing: innovative and emerging approaches to produce medicines. Webinars and Virtual Workshops FDA and Center for Research on Complex Generics Co-Hosted Workshop: Establishing the Suitability of Model-Integrated Evidence to Demonstrate Bioequivalence for Long-Acting Injectable and Implantable Drug Products
This workshop engages experts in the field of modeling and simulation in the generic and new drug industries, academia, and relevant stakeholders to explore, identify and recommend best practices for the development and assessment of model integrated approaches for BE assessment of long-acting injectables and implants. November 30, 2021; 8:30 AM - 5:30 PM ET Conversation on Cancer: "50 Years and Counting: Engaging the Generations on Future Cancer Equity Opportunities" The FDA Oncology Center of Excellence (OCE) joins the entire cancer community in recognizing the 50th anniversary of the National Cancer Act. The Conversations on Cancer public panel discussion will address important cancer drug development achievements during the last five decades. The discussion will feature some of the nation's leading cancer experts focusing on the promise of cancer research and cancer equity for future generations of patients and families. December 13, 2021; 2:00 PM - 3:30 PM ET OTC Monograph Reform: OTC Sunscreen Drugs On September 24, 2021, FDA took steps aimed at improving the quality, safety, and efficacy of sunscreens as part of its implementation of new authorities for certain over-the-counter (OTC) drugs. FDA posted the deemed final order (DFO) for sunscreens which sets the current requirements for marketing OTC sunscreen products. FDA also posted the proposed order for sunscreens to amend and revise this deemed final order for OTC sunscreens products. December 15, 2021; 3:00 PM - 4:00 PM ET Webinar - Draft Guidance: Content of Premarket Submissions for Device Software Functions The FDA will host a webinar for medical device manufacturers and other interested stakeholders to discuss the draft guidance: Content of Premarket Submissions for Device Software Functions. The draft guidance is intended to reflect FDA's most current thinking on the recommended documentation sponsors should include in premarket submissions for FDA's evaluation of the safety and effectiveness of device software functions, including both software in a medical device (SiMD) and software as a medical device (SaMD). December 16, 2021; 1:00 PM - 2:00 PM ET Registration is not required. 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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