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U.S. FDA
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May 21 • 6 tweets • 2 min read
🧵 Recap: FDA announced an important move yesterday toward a Covid-19 booster program that embraces both gold-standard science and common sense. Here are the details: 🧵 For millions of Americans with previous Covid-19 infection(s) and/or vaccine doses, it’s uncertain whether receiving Covid-19 booster shots offers a benefit. Even health care workers are hesitant – less than one third participated in the 2023–2024 fall booster program. It’s time to address this uncertainty with solid evidence.
Aug 16, 2023 • 5 tweets • 1 min read
We’ve seen lots of chatter about ivermectin in the last week. Some of what you’re seeing in videos and social media posts isn’t true. Here are the facts: ⬇️⬇️ 1) Although FDA has approved ivermectin for certain uses in humans and animals, it has not authorized or approved ivermectin for use in preventing or treating COVID-19, nor has the agency stated that it is safe or effective for that use.
Apr 18, 2023 • 12 tweets • 2 min read
Today, FDA amended the EUAs of the Pfizer-BioNTech and Moderna COVID-19 bivalent mRNA vaccines to simplify the vaccination schedule for most individuals. fda.gov/news-events/pr…
What you need to know. 🧵👇 Image This action includes authorizing the current bivalent vaccines (original and omicron BA.4/BA.5 strains) to be used for all doses administered to individuals 6 months of age and older, including for an additional dose or doses for certain populations.
Jan 31, 2023 • 6 tweets • 1 min read
Since the start of the COVID-19 public health emergency [declared under the Public Health Service Act], the U.S. Food and Drug Administration has been committed to providing timely recommendations and regulatory information to support response efforts. Over a dark background, an image of the coronavirus. TEXT: C The COVID-19 public health emergency declared under section 319 of the Public Health Service Act has allowed the FDA to provide important tools and flexibilities to manufacturers, health care facilities, providers, patients, and other stakeholders.
Dec 8, 2022 • 7 tweets • 2 min read
Today, we amended the emergency use authorizations (EUAs) of the updated (bivalent) Moderna and Pfizer-BioNTech COVID-19 vaccines to include use in children down to 6 months of age. fda.gov/news-events/pr… Over a dark background, an image of the coronavirus. The tex Here's what parents and caregivers need to know:
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Dec 6, 2022 • 6 tweets • 2 min read
Today’s “FDA Roundup” includes info on homeopathic drug products, an updated device safety communication, and FDA’s Rare Disease Day. fda.gov/news-events/pr… Newspaper mockup graphic with image of FDA headquarters in t Today, we issued a final guidance, Homeopathic Drug Products, describing the agency’s approach to prioritizing enforcement and regulatory actions for homeopathic products marketed in the U.S. without the required FDA approval. federalregister.gov/public-inspect…
Sep 9, 2022 • 8 tweets • 3 min read
Today’s “FDA Roundup” includes monkeypox testing FAQ info, BiPAP/CPAP safety communication, and a public health alert for an infant formula not manufactured in compliance with the FDA’s infant formula regulations. fda.gov/news-events/pr… Today, we posted FAQs on Testing for Monkeypox with answers to frequently asked questions relating to the development and performance of tests for monkeypox. fda.gov/medical-device…
Aug 31, 2022 • 5 tweets • 2 min read
Today, we amended the authorizations of the Moderna COVID-19 Vaccine and the Pfizer-BioNTech COVID-19 Vaccine to authorize updated formulations of the vaccines for use as a single booster dose at least two months following primary or booster vaccination. fda.gov/news-events/pr… An image of the coronavirus over a dark background. White te These bivalent vaccines, as they are called, contain two messenger RNA (mRNA) components of SARS-CoV-2 virus, one from the original strain of SARS-CoV-2 and the other one in common between the BA.4 and BA.5 lineages of the omicron variant of SARS-CoV-2.
Aug 30, 2022 • 6 tweets • 3 min read
Today’s edition of “FDA Roundup” includes a new FDA Voices, a virtual public listening session announcement, an update on the Philips Respironics recall, and info on a new treatment for chronic constipation. fda.gov/news-events/pr… Today, we published the FDA Voices: “FDA’s Overdose Prevention Framework Aims to Prevent Drug Overdoses and Reduce Death,” by @DrCaliff_FDA.
Jun 15, 2022 • 5 tweets • 2 min read
The FDA is exercising enforcement discretion for the importation of base powder to manufacture Enfamil Stage 1 following the review of information provided pertaining to nutritional adequacy and safety. fda.gov/news-events/pr… Over a blue background, a white exclamation point in a circl About 4.5M pounds of base powder produced by Mead Johnson Nutrition/Reckitt (Singapore) will be imported that can be used to produce about 5.7M cans, or more than 66M full-size, 8-oz bottles.
Jun 14, 2022 • 4 tweets • 2 min read
Today’s edition of the “FDA Roundup” includes an upcoming patient study on breast implants, an EUA for a first-of-its-kind #COVID19 test, and COVID-19 testing updates. fda.gov/news-events/pr… Newspaper mockup graphic with image of FDA headquarters in t Yesterday, FDA’s Center for Devices and Radiological Health announced plans to study how patients weigh the benefits and risks associated with smooth and textured breast implants. fda.gov/medical-device…
May 28, 2022 • 5 tweets • 2 min read
The FDA, along with CDC, Canadian, state, and local partners are investigating a multistate outbreak of hepatitis A in the U.S. & Canada potentially linked to fresh organic strawberries branded as FreshKampo & HEB, purchased between March 5 & April 25. fda.gov/food/outbreaks… An image of strawberries. The text says: Outbreak Alert - FD Currently, the potentially affected FreshKampo and HEB products are past shelf life. People who purchased FreshKampo and HEB fresh organic strawberries between March 5, 2022, and April 25, 2022, and then froze those strawberries for later consumption should not eat them.
May 27, 2022 • 6 tweets • 2 min read
This Friday edition of the “FDA Roundup” includes warning letters on CBD products, a shelf-life extension for a monoclonal antibody, a warning letter, and more! fda.gov/news-events/pr… Newspaper mockup graphic wi... Thursday, we posted warning letters to multiple companies illegally selling CBD products intended for use in food-producing animals.
May 27, 2022 • 7 tweets • 2 min read
Today, we are providing an update on additional steps it has taken that will lead to more infant formula on U.S. store shelves in the coming weeks and months. fda.gov/news-events/pr… Over a blue background, a w... Bubs Australia plans to provide at least 1.25M cans of several varieties of its infant formula such as stage 1 and 2 cans of Bubs Organic Grass Fed, Bubs Supreme A2 Beta-Casein Protein and Bubs Easy-digest Goat Milk, that will make at least 27.5 million full-size, 8-oz bottles.
May 25, 2022 • 10 tweets • 2 min read
False information is circulating on social media stating that COVID-19 vaccines cause monkeypox. That’s just complete nonsense. Here’s the truth…
#FDAVaccineFacts A graphic featuring a vial of COVID-19 vaccine in front of a NONE of the FDA-approved/authorized COVID-19 vaccines can cause monkeypox. The vaccines will not infect you w/SARS-CoV-2 or the monkeypox virus. They do not contain these viruses.
May 24, 2022 • 8 tweets • 2 min read
We’re providing an update on steps FDA has taken that will lead to millions of cans of additional infant and specialty formula being available to U.S. consumers. fda.gov/news-events/pr… Over a blue background, a w... We’ve informed Kendal Nutricare that the FDA is exercising enforcement discretion for the importation of certain infant formula under the Kendamil brand.
May 24, 2022 • 5 tweets • 2 min read
Here’s the latest edition of “FDA Roundup” including guidances on blood establishments, a report on a cooperative agreement, and a marketing approval for a first-of-its-kind product. fda.gov/news-events/pr… Newspaper mockup graphic with image of FDA headquarters in t Monday, we announced the availability of one final guidance and two draft guidances for blood establishments regarding donor eligibility requirements.
May 23, 2022 • 5 tweets • 2 min read
Today, we are updating some meeting dates of our vaccine advisory committee based on new information from vaccine manufacturers and expected EUA requests. The new dates for our pediatric COVID-19 vaccine meetings will now be June 14 and June 15. fda.gov/news-events/pr… Image June 14 will be the new meeting date for the FDA and our advisory committee of external experts to discuss Moderna’s EUA request for 6 years through 17 years.
Mar 21, 2022 • 4 tweets • 2 min read
Today, we announced a virtual meeting of our Vaccines and Related Biological Products Advisory Committee to discuss considerations for future COVID-19 vaccine booster doses and the process for selecting specific strains to address variants. fda.gov/news-events/pr… The April 6 VRBPAC meeting will include discussions about what might warrant updating the composition of COVID-19 vaccines to address specific variants, as well as any considerations regarding the appropriate timing and populations for booster doses in coming months.
Feb 1, 2022 • 7 tweets • 3 min read
Today's “FDA Roundup” includes a new video on food allergy safety, a list of food draft guidances, an annual report, and a COVID-19 test safety communication. fda.gov/news-events/pr… On January 31, we released a new video that provides an overview of the 2021 Food Allergy Safety, Treatment, Education, and Research (FASTER) Act. The FASTER Act adds sesame to the list of major food allergens effective January 1, 2023.
Jan 31, 2022 • 4 tweets • 2 min read
Today, FDA approved a second COVID-19 vaccine for the prevention of #COVID19 disease in individuals 18 years of age and older. fda.gov/news-events/pr… “The FDA’s approval of (the vaccine) is a significant step in the fight against the COVID-19 pandemic, marking the second vaccine approved to prevent COVID-19.” – Acting FDA Commissioner @DrWoodcockFDA