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…the government alleged that eBay sold pill presses and counterfeit dies to hundreds of buyers. Also, DEA and DOJ contend, eBay did not verify purchaser’s identification as required by the…
The first anniversary is always special. Janus-like, it offers the opportunity to simultaneously reflect on hitting a milestone and projecting the future. The first anniversary can also prompt a taking…
…new things of note, and a few other things have been removed (e.g., requirements for sesame allergen labeling, which was accomplished earlier this year). The latest version of the bill…
Over the past several years, FDA has faced criticism stemming from high-profile device issues related to materials, including the Essure permanently implanted birth control device and metal-on-metal hip implants. Given…
…and Bevacizumab.) As the old labeling is shed, the new labeling may not allow for an ANDA (or biosimilar) applicant to easily (if at all) omit information protected by a…
…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 Furthermore, this draft guidance addresses only analytical validity, not clinical validity.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 National Institutes of Health (“NIH”) recently launched a database of labels of dietary supplements being sold in the United States. The database includes, among other information, directions for use,…
By Ricardo Carvajal – FDA released an online learning module intended “to help the seafood industry, retailers, and state regulators ensure the proper labeling of seafood products offered for sale in…
…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…
…Facebook. It would not be surprising, however, to see even greater enforcement focus on privacy, data security, and online marketing matters during Ms. Rich’s tenure. There could also be more…
…online tutorial. As part of “Gut Check,” the FTC is sending letters to 75 broadcasters and media outlets to update them on how to spot bogus claims in weight loss…
By Ricardo Carvajal – The Institute of Medicine (“IOM”) published a summary report of the workshop on caffeine in food and dietary supplements that IOM convened last August at FDA’s…
…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…
…From a field of more than 2,000 potential nominees, FDA Law Blog has received enough nominations to join the 250 legal blogs participating in one of the largest competitions for…