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Webinars – Webinars, whether live streamed or on-demand, can be used for communication with HCPs, HCOs, and POs. A company is responsible for the content of webinars and should take reasonable steps to ensure the audience is targeted and well defined.
Comment topics suggested by DEA include the following: Whether the rule should limit the issuance of prescriptions for controlled medications to FDA-approved indications contained in the labeling for those medications. Helpful practitioner prescribing guidance is set forth in a simplified document here. Stay tuned.
Omnicell continues to collaborate with ISMP to improve pharmacy-nursing efficiency, reduce medication errors during dispensing, and support accurate medication tracking and documentation of inventory and deter drug diversion. Watch this webinar to learn more about how automated dispensing systems support ISMP guidelines for medication safety.
By Philip Won & Véronique Li, Senior Medical Device Regulation Expert — As we recently blogged , FDA released three draft guidance documents to help enhance the predictability, consistency, and transparency of the 510(k) program. One of these documents focuses on “ Evidentiary Expectations for 510(k) Implant Devices.”
In the years leading up to 2022, numerous publications were issued; networking events, webinars, and conferences were held; and regulatory panel discussions with regulators performed. Is the vendors’ documentation complete in order to assess GxP risks and GxP compliance? and management communication strategy.
Join our next Awesome Webinar Series with guest legal guru JD from Real Value Rx to answer any questions you have about the DSCSA delay. To be authorized: Pharmacies should ensure they receive, maintain, and update these documents as necessary to continue ordering from their ATP and be ready to provide copies of them upon request.
Under the proposed rule, any raw whole fruits and vegetables could be labeled healthy no matter the level of added sugars, sodium, or saturated fat. FDA also plans to host a stakeholder webinar on the final rule at a later date. The final rule does not limit this exemption to only raw fruits and vegetables.
Lenz, Principal Medical Device Regulation Expert In early January, FDA released a draft guidance document titled Artificial Intelligence-Enabled Device Software Functions: Lifecycle Management and Marketing Submission Recommendations (Draft AI Guidance). By Adrienne R. User Interface Software Description Section VI.B
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