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Management: Food and Drug Administration (FDA)

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Total 1110 results found since Jan 2013.

An FDA advisory group confirmed some popular decongestants are ineffective. Now what do we do?
WASHINGTON -- Just in time for fall and winter sniffles, an advisory committee to the US Food and Drug Administration has decided that a popular ingredient in oral cold and allergy medications doesn't work. What do we do now? "There's so many options out there," said Dr. David C. Brodner, an…#davidcbrodner #boyntonbeach #florida #fda #brodner #mucinex #flonaseornasacort #neti #richardjharvey #macquarieuniversity
Source: Reuters: Health - September 16, 2023 Category: Consumer Health News Source Type: news

Decongestants in popular cold, allergy medicines don ’t work, FDA says
An advisory panel to the U.S. Food and Drug Administration (FDA) has found that the primary ingredient in many cold and allergy medications is ineffective. The advisors said in a unanimous vote that medications containing phenylephrine that are taken orally, such as Mucinex, Sudafed, Nyquil and…#fda #mucinex #benadryl #universityofflorida #njcom #katherinerodriguez #njcomtips
Source: Reuters: Health - September 15, 2023 Category: Consumer Health News Source Type: news

With the Decongestant SNAFU, the FDA Tries Something New
It’s easy to understand how a medicine like phenylephrine got onto pharmacy shelves in the first place. The common decongestant, used most often as an ingredient in multidrug cold medications like DayQuil and Sudafed PE, was initially designated as “safe and effective” by the Food and Drug Administration (FDA) in 1976, when the agency was newly—and less stringently than today—greenlighting drugs that had been on the market for years before the agency had established any efficacy standards. After a full review of 14 studies (12 unpublished and two published) from pharmaceutical companies—...
Source: TIME: Health - September 14, 2023 Category: Consumer Health News Authors: Haley Weiss Tags: Uncategorized healthscienceclimate Source Type: news

Adverse events associated with budesonide nasal irrigation reported to the US Food and Drug Administration: 2007 to 2022
KEYPOINTS Between 2007 and 2022, the FDA received 119 US-based reports mentioning budesonide nasal irrigation. Most reports were submitted by patients and alerted FDA to off-label usage of budesonide. Notable adverse events reported to the FDA included headache, dyspnea, and blurred vision.
Source: International Forum of Allergy and Rhinology - August 22, 2023 Category: Allergy & Immunology Authors: Vinay K. Rathi, Nicholas W. Sawicki, Rodney J. Schlosser, Zachary M. Soler, George A. Scangas, Alan D. Workman, Stacey T. Gray Tags: RESEARCH NOTE Source Type: research

Breakfast sandwiches recalled in Kansas over allergy fears
Federal health officials say a line of breakfast sandwiches are being recalled by the company that made them over allergy worries. The U.S. Food and Drug Administration (FDA) said Mondelēz Global LLC announced on July 3 that two varieties of belVita Breakfast Sandwich products manufactured in the…#fda #mondelēzglobal #llc #breakfastsandwich #kansas #bestwhenusedbydates
Source: Reuters: Health - July 5, 2023 Category: Consumer Health News Source Type: news

Adverse events associated with budesonide nasal irrigation reported to US food and drug administration, 2007 ‐2022
Source: International Forum of Allergy and Rhinology - July 3, 2023 Category: Allergy & Immunology Authors: Vinay K. Rathi, Nicholas W. Sawicki, Rodney J. Schlosser, Zachary M. Soler, George A. Scangas, Alan D. Workman, Stacey T. Gray Tags: RESEARCH NOTE Source Type: research

News at a glance: Muscular dystrophy therapy, lab-grown chicken, and humans ’ toll on wildlife
BIOMEDICINE Muscular dystrophy therapy approved The U.S. Food and Drug Administration has approved the first gene therapy for Duchenne muscular dystrophy (DMD), a genetic disease that cripples boys and usually results in death by age 30. The treatment from Sarepta Therapeutics introduces a short version of the gene for dystrophin, a crucial muscle protein, which is mutated in patients with DMD. A one-time intravenous infusion of a virus delivers the functioning “microdystrophin” gene into patients’ muscle cells. The 22 June approval is only for boys 4 to 5 years old, a group that appeared likely to ben...
Source: Science of Aging Knowledge Environment - June 29, 2023 Category: Geriatrics Source Type: research

Check your pantry: Frito-Lay issues allergy alert for an undeclared salsa dip ingredient
Frito-Lay has issued a voluntary recall of Tostitos Avocado Salsa Jar Dip because it may contain an undeclared milk allergen, according to the US Food and Drug Administration.
Source: CNN.com - Health - June 25, 2023 Category: Consumer Health News Source Type: news

Innovations in the Treatment of Anaphylaxis: A Review of Recent Data
Ann Allergy Asthma Immunol. 2023 Jun 4:S1081-1206(23)00404-0. doi: 10.1016/j.anai.2023.05.033. Online ahead of print.ABSTRACTPURPOSE OF REVIEW: The current standard of first-line emergency treatment of anaphylaxis is intramuscular (IM) epinephrine administered most commonly via epinephrine autoinjector (EAI) in the outpatient setting. However, undercarriage and underuse of EAIs are common, and delayed epinephrine use is associated with increased morbidity and mortality. Patients, caregivers, and healthcare professionals have expressed a strong desire for small, needle-free devices and products that would offer improved car...
Source: Annals of Allergy, Asthma and Immunology - June 6, 2023 Category: Allergy & Immunology Authors: Jay A Lieberman John Oppenheimer Vivian P Hernandez-Trujillo Michael S Blaiss Source Type: research

FDA Approves Pfizer ’ s New RSV Vaccine for Older Adults
After decades of having no vaccines to fight respiratory syncytial respiratory (RSV), the U.S. now has two—both aimed at protecting older adults. On May 31, the U.S. Food and Drug Administration (FDA) approved the second RSV vaccine in the world. The first, from the pharmaceutical company GSK, gained FDA approval earlier in May for adults age 60 and older. The newest vaccine, made by Pfizer, will also target people in the same age group. RSV causes respiratory disease that can affect everyone, but elderly adults and young babies typically experience the most severe illness. Between 60,000 and 160,000 American seniors...
Source: TIME: Health - May 31, 2023 Category: Consumer Health News Authors: Alice Park Tags: Uncategorized Drugs healthscienceclimate Source Type: news

Companies won ’t share COVID-19 shots, stalling future vaccine research
The U.S. government has tens of millions of unused doses of messenger RNA (mRNA) COVID-19 vaccines, regularly trashing shots as they pass their expiration dates. It’s a dismal reflection on recent vaccine uptake, but it’s also a serious roadblock for scientists testing and developing vaccines that could protect against future variants of SARS-CoV-2—and the next pandemic. Developers need existing vaccines as a benchmark to compare with new candidates. But government contracts with the vaccinemakers, and the companies’ own policies, prohibit the use of the vaccines for research purposes. “At this stage of the ...
Source: ScienceNOW - May 30, 2023 Category: Science Source Type: news

FDA advisers clear hurdle for epinephrine nasal spray
A Food and Drug Administration (FDA) advisory panel has approved an epinephrine nasal spray, clearing a hurdle for the product designed to help those with severe, potentially life-threatening allergic reactions. The panel, the Pulmonary-Allergy Drugs Advisory Committee, voted on Thursday to…#fda
Source: Reuters: Health - May 13, 2023 Category: Consumer Health News Source Type: news