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…ads. Additional consumer education materials The FTC has also created a website advertising a fake weight loss product called “FatFoe.” FatFoe is not a real weight loss product. The ad…
…Caffeine Effects on the Cardiovascular System Caffeine effects on the central nervous system and behavioral effects associated with caffeine consumption Other compounds impacting caffeine effects In a concurrently issued press…
…the Court already enjoined.” Zogenix also alleged that the regulations violate the Contract Clause and the Commerce Clause of the U.S. Constitution, as well as the Equal Protection Clause “by…
By Jeffrey K. Shapiro – FDA is authorized by the Federal Food, Drug, and Cosmetic Act of 1938, as amended (FDCA) to regulate the labeling of all medical devices and…
…level, and found incorrect identification of fish species 15% of the time. Almost all mislabeling occurred in the snapper and grouper categories. It remains to be seen whether the educational…
…of any Federal law as a controlled substance in Schedule I.”)) Schedule I substances have a high potential for abuse, have no currently accepted medical use in treatment in the…
…warning letters in the clinical trial space, among its other efforts. FDA components aren’t always forthcoming with initiatives and statistics that provide insight into policy priorities. Additionally, annual reports can…
…of all parties, including those of managed care pharmacy, are taken into consideration.” Letter from Edith A. Rosato, RPh, Academy of Managed Care Pharmacy, to Tom Frieden, CDC, (Sept. 18,…
…Product Codes for the categories of LDTs the Final Rule identifies as being subject to potential enforcement discretion for all regulatory requirements, including MDR requirements (i.e., 1976-type LDTs; Human Leukocyte…
…the final rule for Sanitary Transportation of Human and Animal Food. Although FSMA directed FDA to issue this rule, the rule implements the Sanitary Food Transportation Act of 2005 (SFTA)….
…should not be totally “open” to the public. For example, some portions of cases may involve trade secrets or other confidential commercial information. However, we can also see some benefits…
…complaints, including minor to major medical events, but also complaints about non-medical issues such as off-taste or color of a product. Information in the database includes demographic (e.g., age, gender)…
…can be expected to generate a significant volume of comments. For example, AMS asks for input on allowable terminology; types of modifications that should be exempt from disclosure; what the…
…claims about boosting children’s immunity and cognitive function. Privacy and data security cases were not uncommon during Mr. Vladeck’s tenure; several settlements were announced with companies, such as Google and…
…as MEDLINE and PubMed) and online scientific and medical publishers (such as the Public Library of Science (PLoS) and the Cochrane Library).” The draft guidance also clearly states that because…