The FDA Law Blog

FEBRUARY 27, 2023

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. We will release exciting details of our upcoming webinar addressing telemedicine soon. Stay tuned.

Controlled Substances 59

Controlled Substances FDA Documentation Communication 59

pharmaphorum

OCTOBER 27, 2022

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.

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Communication Packaging Documentation Pharmaceutical Companies 98

Omnicell

SEPTEMBER 5, 2022

For example, we all know the importance of ensuring that syringes are labeled whenever medications are prepared but not immediately administered. 28 at 1 pm EST/10 am PST for the Omnicell Live webinar, “Medication Safety Perspectives: Best Practices in Hospital Pharmacies.”

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Omnicell Hospitals Patient Care Labelling 52

InCrowd

JULY 17, 2024

In Apollo’s recent webinar , moderated by Glenna Crooks, Ph.D. Traditionally reliant on established methodologies, HEOR is now rapidly incorporating RWD and Real-World Evidence (RWE) to support label expansions and integrate with conventional research activities. For more context and a complete discussion, watch the webinar today.

Medical Records 52

Medical Records Labelling 52

Pharma Marketing Network

FEBRUARY 19, 2025

Drug names and indications must align with FDA-approved labeling. signing up for a webinar, downloading a whitepaper)? FDA and Fair Balance Messaging All promotional emails must include fair balance messaging benefits and risks must be presented equally. No personal health information (PHI) can be used for targeting or personalization.

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HIPAA FDA Communication Labelling 72

Omnicell

JANUARY 10, 2023

Omnicell XT cabinets support automated printing of a label with a machine-readable barcode to help nurses verify the right medication is being administered to the right patient.  Watch this webinar to learn more about how automated dispensing systems support ISMP guidelines for medication safety.

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Omnicell Documentation Labelling Patient Care 52

ISPE

JULY 19, 2023

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. and management communication strategy. ™ hackathons were established, and the ISPE Factory of the Year (FOYA) award category was created.

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Documentation FDA Communication Labelling 98

The FDA Law Blog

OCTOBER 10, 2023

Labeling and Implant ID Card Lastly, it is critical that patients are provided with implant information as it pertains to their devices. separate patient labeling). Manufacturers should create user-friendly instructions for use that facilitate patient understanding of potential risks over the expected lifespan of the implant.

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FDA Documentation Labelling Communication 45

DiversifyRx

JULY 11, 2024

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. Small Dispensers and the 6/12/2024 FDA Announcement Concerning DSCSA This week’s article on the recent DSCSA postponement comes from PRS Pharmacy Services. The original article can be found HERE.

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Independent Pharmacies FDA Documentation CPhT 52

Birth Control Pharmacist

MARCH 29, 2021

I recently had the opportunity to attend the Sex & Gender 101 webinar designed to help anyone in the healthcare field learn more about creating trans inclusive care. The term nonbinary is a specific gender identity label and an umbrella term.

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Labelling 52

The FDA Law Blog

JANUARY 2, 2025

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.

FDA 52

FDA Labelling Documentation 52

Pharma Marketing Network

MARCH 18, 2025

Being aware of pharmaceutical advertising laws, fair balance requirements, and off-label promotion restrictions will prevent costly compliance mistakes. Combining HCP webinars, digital advertising, and interactive medical content enhances outreach effectiveness. Organizations like the FDA (U.S.),

Communication 52

Communication Labelling FDA 52

The FDA Law Blog

FEBRUARY 5, 2025

Labeling Labeling Section VII Risk Assessment Risk Management File of Software Documentation Section VIII Data Management Data for development: Software Description of Software Documentation Data for testing: Performance Testing Section IX Model Description and Development Software Description Section X.A

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Documentation FDA Labelling Communication 95

The FDA Law Blog

FEBRUARY 20, 2025

While not terribly informative, under the prior administration, FDA held a webinar to outline the requirements of this Stage. The materials from this webinar are still available on FDAs website ( here ). Since the new administration took office, however, the webinar page has been taken down from FDAs website.

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FDA Communication Labelling 102