Posts tagged with: "fda"
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29 Apr 2024, 10:00 pm
FDA recently issued a revised draft guidance titled Promotional Labeling and Advertising Considerations for Prescription Biological Reference Products, Biosimilar Products, and Interchangeable Biosimilar Products . [read post]
29 Apr 2024, 10:00 pm
FDA recently issued a revised draft guidance titled Promotional Labeling and Advertising Considerations for Prescription Biological Reference Products, Biosimilar Products, and Interchangeable Biosimilar Products . [read post]
29 Apr 2024, 10:00 pm
FDA recently issued a revised draft guidance titled Promotional Labeling and Advertising Considerations for Prescription Biological Reference Products, Biosimilar Products, and Interchangeable Biosimilar Products . [read post]
29 Apr 2024, 8:14 pm
This is the third letter from some of the same Democratic lawmakers to the Attorney General and DEA Administrator on marijuana rescheduling since the Food and Drug Administration (“FDA”) and Health and Human Services (“HHS”) recommended rescheduling in schedule III last August. [read post]
29 Apr 2024, 5:00 pm
Since FDA issued its Proposed Rule (the “Proposed Rule”) in the Fall of 2023, Epstein Becker Green (EBG) and other industry stakeholders have eagerly awaited FDA’s issuance of the Final Rule and have speculated as ... [read post]
29 Apr 2024, 11:42 am
” The FDA’s website warns patients that the risks of ingesting the sound-dampening foam could include headache, asthma, allergic reactions and more serious problems. [read post]
29 Apr 2024, 4:50 am
Findings will help inform public health campaigns as FDA considers new regulations on very low nicotine and menthol cigarettes. [read post]
28 Apr 2024, 9:03 pm
After the inspection, the FDA investigator issued a Form FDA-483, Inspectional Observations, listing deviations found at the facility. [read post]
28 Apr 2024, 7:32 pm
Reed Smith will continue to follow developments with regard to the FDA’s regulation. [read post]
26 Apr 2024, 1:36 pm
Report the Competitor to a Federal or State Regulator On the federal level, this is usually the Federal Trade Commission (FTC), the Federal Communications Commission (FTC), or the Food and Drug Administration (FDA). [read post]
26 Apr 2024, 7:03 am
FDA (D.D.C.) -- in case concerning agency’s denial of market approval for plaintiff’s e-cigarette products, concluding that: (1) agency properly relied on Exemption 5’s deliberative process privilege to withhold certain review memos drafted by agency scientists, as well as one “Technical Project Lead” review memo, but ordering FDA to review records submitted in camera that appeared to contain “purely descriptive” material; and (2)… [read post]
26 Apr 2024, 6:36 am
In the first of two pivotal decisions this term, the Court will decide whether FDA properly expanded access to mifepristone. [read post]
26 Apr 2024, 4:50 am
"Consumers are deeply troubled by the FDA's abject failure to fulfill its obligations under the Tobacco Control Act," said Hicks. [read post]
26 Apr 2024, 3:00 am
” While FDA recalled roughly the same number of products every year since the pandemic, USDA issued 31% more recalls in 2023 compared to the previous year, according to the report. [read post]
25 Apr 2024, 9:25 pm
In the new definition, FDA removed the phrase, “that is devised for the promotion of a product,” broadening the definition of “promotional labeling” to potentially encompass any labeling other than the FDA-required labeling. [read post]
25 Apr 2024, 6:05 pm
FDA v. [read post]
25 Apr 2024, 6:41 am
Journalists Signal Upcoming Story Lines with FOIA RequestsFOIAengine: Insights From the Latest FDA and SEC Requests By Randy Miller, Law Street, Apr. 24, 2024News media outlets are among the most prolific submitters of FOIA requests to federal agencies. [read post]
24 Apr 2024, 9:05 pm
The only other active outbreak investigation under FDA jurisdiction is related to organic, fresh basil. [read post]
24 Apr 2024, 5:35 pm
” This conclusion means that OMB has returned the final rule to FDA with changes. [read post]
24 Apr 2024, 5:59 am
Last fall, the drug manufacturer Eli Lilly received approval from the Food and Drug Administration (FDA) for a new medication for chronic weight management. [read post]
