…will be issued in Feb. 2017 and will cover data submitted to CAERS during Oct.-Dec. 2016. The second quarterly report will be issued in May 2017 and will cover reports…

…threshold for disclosure should be; how disclosures should be made for bulk, vending machine, and online purchases; how AMS should define very small or small packages for purposes of special…

…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,…

…marketing.  One point to bear in mind if you attempt to Google-search for the new database: an older and far more limited NIH database of dietary supplement labels remains online. …

…comply with the World Health Organization (“WHO”) Model Quality Assurance System; Use of a uniform document format for product registration by regulatory authorities in low- and middle-income countries, and creation…

…telemedicine solutions to receive needed controlled substance medications, the Declaration’s expiration would also put an end to DEA’s flexibilities permitting certain exemptions to the Ryan Haight Online Privacy and Consumer…

…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…

…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…

…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…

…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…

…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….

…since the CCP was originated) received an email from CDRH announcing that “Soon, FDA will let you send new CDRH-led premarket submissions online through our Customer Collaboration Portal (CCP) instead…

…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…

…is defined in the new guidance as “sponsors or requestors for an OTC monograph drug”. We note that a search for “requestor” in the Merriam-Webster dictionary online provided the result…