As you and other public health advocates work on the front lines of the COVID-19 pandemic, we want you to know that we recognize your concerns about protecting the safety of yourselves, your families, and others you care for. The FDA's work is critical to ensuring the health and safety of the American public at any time, but is magnified during public health emergencies.
As we address the challenges of the COVID-19 pandemic, protecting the public's health, using science to guide our decisions, and facilitating access to critical medical products continue to be top priorities for the FDA.
COVID-19 Container Closure System and Component Changes: Glass Vials and Stoppers Guidance for Industry: Guidance for Industry FDA is issuing this guidance to collate recommendations for appropriate reporting category and the content of postapproval change submissions across numerous FDA guidance documents. This guidance conveys recommendations to holders of approved new drug applications (NDAs), biologics license applications (BLAs), and abbreviated new drug applications (ANDAs) regarding the reporting and implementation of some common changes to container closure system (CCS) components consisting of glass vials and stoppers for approved sterile drug products, including biological products, administered parenterally.
Patients today have more treatment options in the battle against coronavirus disease. The FDA 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. [03/11/2021]
If you're taking a medication, is it safe to drive?
Most likely, yes. Still, the FDA advises you to make sure before operating any type of vehicle, whether a car, bus, train, plane, or boat.
Although most medications won't affect your ability to drive, some prescription and nonprescription medicines (also called over-the-counter, or OTC) can have side effects and cause reactions that may make it unsafe to drive. Side effects can include:
sleepiness/drowsiness
blurred vision
dizziness
slowed movement
fainting
inability to focus or pay attention
nausea
excitability
Some medicines can affect your driving for a short time after you take them. For others, the effects can last for several hours, and even the next day. And some medicines have a warning to not operate heavy machinery — this includes driving a car. [03/09/2021]
COVID-19. We've been living with it for what sometimes seems like forever. Given the number of deaths that have occurred from the disease, it's perhaps not surprising that some consumers are looking at unconventional treatments, not approved or authorized by the FDA.
Though this is understandable, please beware. The FDA's job is to carefully evaluate the scientific data on a drug to be sure that it is both safe and effective for a particular use, and then to decide whether or not to approve it. Using any treatment for COVID-19 that's not approved or authorized by the FDA, unless part of a clinical trial, can cause serious harm. [03/05/2021]
Roadmap to 2030 for New Drug Evaluation in Older Adults This workshop will bring together stakeholders from academia, industry, and regulatory agencies in a virtual setting to discuss the current status of inclusion of older adults in clinical trials and strategies to ensure the safe and effective use of drugs in this population
March 24 - 25, 2021; Day 1 : 9:00 AM - 4:30 PM ET, Day 2: 10:00 AM - 1:00 PM ET
Registration is not required.
Nitrosamines as Impurities in Drugs; Health Risk Assessment and Mitigation Public Workshop The workshop will include presentations on nitrosamines chemistry and toxicology and, on the finding of nitrosamines as impurities in drugs. The presentations will be followed by open discussion of questions prepared by the FDA and presented to expert panelists for deliberations over 2 days.
March 29 - 30, 2021; Day 1: 9:00 AM - ET, Day 2: 9:00 AM - ET
Registration is required for online attendance and will be available until 4PM ET on March 26, 2021.
The FDA Stakeholder Engagement Staff reside within the Office of the Commissioner and support the FDA mission by engaging with Patient and Health Professional Organizations, Consumer Groups, Trade Associations, Think Tanks and other external stakeholders. We encourage and support active engagement from external stakeholders related to policy that impacts human and animal medical products, cosmetics, tobacco, nutrition and food safety that promote health and healthy living.
This email was sent to ooseims.archieves@blogger.com using GovDelivery Communications Cloud on behalf of: U.S. Food and Drug Administration · 10903 New Hampshire Ave · Silver Spring, MD · 20993-0002 · 1-888-INFO-FDA
No comments:
Post a Comment