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…the final rule does not cover MUSA claims in all advertising. Instead, it covers labels appearing in all contexts, whether, for example, they appear on product packaging or online. FTC…
…environmental, social and financial demands and concerns to ensure responsible, ethical and ongoing success of a company. That is a whole lot wrapped into one word, a great deal of…
…510(k)s. The pilot will be available to applicants planning to submit Traditional, Special, or Abbreviated 510(k)s. Interested applicants should contact CBER, at the email in the Federal Register notice. These…
…they are unable or unwilling to access care in clinical settings? What processes and medical procedures, including diagnostics, do you believe would be ideal for transitioning from a hospital and/or…
…CDRH 510(k) submission (traditional, special, and abbreviated 510(k)s) for review, your official correspondent can monitor the FDA’s progress online in a simple, concise format.” The tracking feature is useful to…
Allegations of regulatory misconduct are claims that a medical device manufacturer or marketers of medical devices operate in such a way that violates the law. Allegations may include failure to…
…also clarified that all hearing aids, OTC or otherwise, are subject to Quality System Requirements (“QSRs”). While FDA addressed some major controversial issues that arose from the Proposed Rule, other…
…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….
The Orange Book’s Therapeutic Equivalence Codes (TE Codes) play a critical role in our drug distribution and payment system. All states have “automatic substitution” laws that require prescriptions to be…
…provisions, but notes that although certain information about a formal meeting may be publicly available, a formal meeting is not open to the public. One issue of interest not addressed…
…court to seek equitable relief. In contrast, 13(b) allows the FTC to go to court to enjoin allegedly unlawful conduct without providing any notice at all to the alleged violator….
…are taking to alleviate disruptions; and how these companies allocate products among their stores when they are in short supply.” The orders also seek internal company documents such as “strategies…
…summary also appears to remain available even once a final decision is made on the 510(k). To date, completed 510(k) submissions are still showing in the CCP. This historical reference…
…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…