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FDA Calls for Child-Resistant Packaging on Nicotine Pouches to Protect Children
06 Sep 2025 00:17 GMT
… FDA also said that twenty nicotine pouch products have already received marketing … resistant packaging.
The FDA also encourages manufacturers … according to the FDA.
The FDA warned that concentrated … and vomiting.”
– FDA
The FDA also issued consumer guidance …
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Ninth Circuit Affirms Dismissal of Securities Fraud Suit: Marketing Slogan Alone Not Actionable Under Section 10(b) and Rule 10b-5
05 Sep 2025 23:51 GMT
… clarifies the interplay between marketing materials, context and the … Food & Drug Administration (“FDA”) required a strict Risk … after administration.
The FDA issued warning letter about … disagreed: “Just because the FDA requires disclosure of specific …
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FDA calls on nicotine pouch manufacturers to use child-resistant packaging amid a rise in accidental exposures
05 Sep 2025 23:03 GMT
… caused by nicotine pouches,” FDA Commissioner Dr. Marty Makary … and ingestion.”
The FDA noted in its announcement … resistant packaging. The FDA gave marketing authorization to certain nicotine … headache and vomiting.
The FDA offered information for consumers …
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FDA releases denial letters for unapproved drugs, a step toward transparency
05 Sep 2025 22:41 GMT
… the release of 89 marketing denial letters, called Complete … Commissioner at FDA, and previously cited by FDA Commissioner Makary, … learning across development programs.” FDA is under constant pressure … working on a comprehensive FDA transparency report, funded …
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States Join FDA in the MAHA War on Food Ingredients
05 Sep 2025 21:00 GMT
… remove color additives and related marketing statements.
Affected companies should take … children and informing transparent FDA rulemaking.”
In April, FDA and HHS announced … information about this ingredient, including FDA approvals, click HERE.” In addition …
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Vaccine Suspension: FDA Leans Into Its Withdrawal Toolbox, But Will It Invite Challenges?
05 Sep 2025 20:56 GMT
… authority to suspend a granted marketing authorization for approved drug … concurrent suspension of marketing authority.
Supporting its decision, FDA released a memorandum … of a marketed product. While marketing approval technically remains intact, suspension …
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FDA to modernise review process for developers of ultra-rare diseases
05 Sep 2025 13:02 GMT
… trial sponsors that the FDA’s assessments will encompass … principles ensure that [the FDA] … incorporate confirmatory evidence to … as post-marketing requirements, according to the FDA.
FDA Commissioner Dr … These principles ensure that FDA and sponsors are …
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FDA releases previously unseen CRLs in transparency push
05 Sep 2025 11:50 GMT
… issued to sponsors."
FDA Commissioner Dr Marty Makary … that were eventually cleared for marketing, the new batch included … same lines as other published FDA correspondence like warning letters. … a devastating truth — the FDA moved the goalposts." …
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Southern Nevada Health pauses old COVID shots, preps for new formula under FDA rules
05 Sep 2025 06:57 GMT
… Jr. stated that the FDA has issued marketing authorization for those at …
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Kardium receives FDA OK for pulsed field ablation system
04 Sep 2025 18:10 GMT
Dive Brief:
Kardium has received premarket approval for its Globe pulsed field ablation system, as well as 510(k) clearances for both the Globe Introducer sheath and mapping software, the company said Wednesday.
The Food and Drug Administration …