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Last week, FDA did something unprecedented (although not unexpected, at least by this blogger)! And based on the absence of any reporting in the trade press or online chatter, nobody…
…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…
…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…
…device intended for commercialization, test methods, especially for extraction, and interpretation of results. On March 19, 2021, FDA announced the launch of an online Biocompatibility Assessment Resource Center to provide…
…promotion, category captain and online retail sales. The information the FTC is collecting, the comments it is soliciting, and the hearings it will hold will eventually be distilled down to…
Earlier this fall, in accordance with its MDUFA IV commitments, CDRH launched an online platform that allows sponsors to track the status of its submissions. The platform is called the…
…2020, DEA announced a “proactive collaboration with online e-commerce companies” to inform and educate e-commerce companies about the requirements and importance of safeguarding these products and ensuring they do not…
…established a new category of OTC hearing aids for individuals with mild to moderate hearing loss, allowing them to purchase hearing aids directly from stores or online retailers without the…
…establish requirements for the sale of food online, including access to label or labeling information prior to purchase The bill does not include any provisions to fund the work to…
…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…
…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…
…verify a purchaser’s date of birth by means of photographic identification. The results of FDA’s compliance checks can be accessed online in a database that is searchable by retailer name…
…used to determine the rebates paid to states under the Medicaid program. The court also enjoined the government from posting any AMP data online or disclosing the data to any…
…online pharmacies, and drug-related import alerts were key tools for OC’s efforts to safeguard the drug supply chain from adulterated products over the prior fiscal year. Communication in this area…
…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…