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…any potential harm to the government, and (4) it is in the public interest for agencies to comply with the law and Medicaid beneficiaries to obtain access to local pharmacies….
…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…
…all records related to the Cafepharma.com postings. In two other letters unrelated to the Cafepharma.com postings, the Oversight and Investigations Subcommittee also requests detailed information from FDA and Merck/Schering-Plough on,…
…with a direct final rule. FDA ultimately withdrew the direct final rule because it received “significant adverse comment[s].” After considering the comments, on February 19, 2013, FDA issued a supplemental…
…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…
…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)…
…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…
…small subset of potential applications. Furthermore, this draft guidance addresses only analytical validity, not clinical validity. Both analytical and clinical validity are required to demonstrate a reasonable assurance of safety…
…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)….
…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,…
…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…
…legal blog writing online today. Now that the blogs have been nominated and placed into their respective categories, it is up to their readers to select the very best. With…
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…
…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…
…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…