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Posts tagged as “FDA”

FDA Draft Rules Provide Clarity for Consumers and Producers on Plant-Based Drinks Labeling

The FDA has released draft rules allowing plant-based drinks to label themselves as "milk" and providing voluntary extra nutrition labels to note when the drinks have lower levels of certain nutrients than dairy milk. The rules are open for public comment until April 13, 2021, and will provide clarity for consumers and producers when the final rule is issued.

FDA Advisory Committee Unanimously Recommends Over-the-Counter Naloxone to Combat Opioid Crisis

The FDA advisory committee has voted unanimously to recommend that a nasal spray version of naloxone, a medication used to reverse opioid overdoses, be sold over-the-counter. If approved, the drug would be more widely available and accessible to those who need it, potentially helping to save lives and reduce the number of opioid-related deaths. The FDA is expected to make a decision on the request in the coming weeks.

CDC Warns of Drug-Resistant Infections Linked to Over-the-Counter Eye Drops, Global Pharma Healthcare Issues Recall

The US Centers for Disease Control and Prevention (CDC) is warning people to stop using the over-the-counter eye drops, EzriCare Artificial Tears, due to an outbreak of drug-resistant infections of Pseudomonas aeruginosa. The CDC has received reports of 55 infections in 12 states, including one fatality, and Global Pharma Healthcare is issuing a recall of the product. The FDA is continuing to investigate the source of the contamination and the CDC is urging people to seek medical attention if they have used the product and are experiencing any symptoms.

Republican Attorneys General Warn CVS and Walgreens Against Mailing Abortion Pills in Their States

Republican attorneys general from 20 states have written letters to CVS and Walgreens executives warning them against using the mail to dispense abortion pills in their states, in opposition to the Biden administration's new policy. The attorneys general argue that the new policy could lead to a lack of oversight and regulation of the abortion pill, putting women's health at risk, and an increase in the number of abortions in their states. They have asked the pharmacy chains to comply with their state laws and not distribute the abortion pill through the mail.

FDA Proposes New Guidelines to Ease Restrictions on Blood Donations from Gay and Bisexual Men and Other Groups

The U.S. Food and Drug Administration (FDA) has proposed new guidelines that would ease restrictions on blood donations from gay and bisexual men, doing away with the three-month abstinence requirement. The proposal has been welcomed by gay rights groups, and if finalized, it would be the latest FDA move to broaden donor eligibility and potentially boost the U.S. blood supply. The FDA is now seeking public comment on the proposed guidelines before deciding whether to finalize the new rules.

FDA Proposes New Action Levels to Reduce Lead Exposure in Baby and Toddler Foods

The US Food and Drug Administration has proposed a new draft guidance to set the allowable levels of lead in certain baby and toddler foods to 20 parts per billion or less. This could result in a 24-27% reduction in exposure to lead from these foods for babies and young children. The FDA is now seeking public comment on the proposed guidance to help inform their decision-making process.

FDA Proposes Major Change to US Covid-19 Vaccine Strategy, Making it More Similar to Annual Flu Shots

The US Food and Drug Administration (FDA) has proposed a major change to the country’s approach to COVID-19 vaccines, making it more similar to the annual flu vaccine push. The FDA would assess circulating strains of the virus and decide in June which strains to include in the vaccine. If implemented, the change could simplify the process of getting vaccinated against Covid-19 and help ensure that people are protected against the most common strains of the virus.