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…adverse event data for products it marketed. While BioTe Medical (who was inspected by FDA) evidently had an online portal to collect adverse drug event information, and collected over 4000…
…alone would be worth the price of admission (if admission weren’t free). Those coming late to the party can still join in remotely by registering for the online webcast here….
…orders. Finally, last Wednesday, DEA announced that is adding to its ARCOS Online Reporting System the ability for manufacturers and distributors “to view the number of competitors who have sold…
…FDA to conduct an analysis of drugs that may be vulnerable to a shortage, and to publish the notifications it receives under § 356c online. The “Preserving Access to Life-Saving…
…of “readily available” by providing examples, including “bibliographic databases of life sciences and biomedical information (such as MEDLINE and PubMed) and online scientific and medical publishers (such as the Public…
…collaboration related to the Internet and the unprecedented growth in illegal drug sales via the Internet, including the online trade of counterfeit, adulterated, misbranded, and unapproved drugs. Import Shipments– The…
…there are online sales. Adding disclaimer language with classic “waffle” words, like “should,” “expect,” or “endeavor” may help to keep the CSR statements aspirational. But do know that courts are…
…Medical School, Columbia University, Vanderbilt University, the University of Minnesota, and other leading genomics and regulatory institutions will convene online to tackle these issues. Hyman, Phelps & McNamara PC is…
…NDAs. Details explaining the assignment and meaning of the TE Codes are published in the Preface of the hard copy (or now, the online PDF copy) of the Orange Book….
…Contacts, 2018 WL 6078349 (F.T.C. 2018) (FTC order resolving antitrust case alleging anticompetitive practices in the online contact lens market). As noted above, this is a case where it is…
…or distribution of over-the-counter hearing aids . . . through in-person transactions, by mail, or online, that is different from, in addition to, or otherwise not identical to, the regulations…
…monitor, fall detector, actigraphy, etc.), telemedicine and telehealth solutions (e.g., enable individuals to have virtual consultations with healthcare providers through video calls or online platforms), at-home diagnostics (e.g., pregnancy tests,…
…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…
…provide information on ongoing investigations, information can be obtained through a Freedom of Information Act (FOIA) Request.” FOIA requests can be submitted online. FDA encourages waiting at least 6 months…
…hearing aids, as defined under section 520(q) of the Federal Food, Drug, and Cosmetic Act, through in-person transactions, by mail, or online.” While some comments, including those from 41 State…