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. Helpful practitioner prescribing guidance is set forth in a simplified document here. Stay tuned.

Controlled Substances 59

Controlled Substances FDA Documentation Labelling 59

The FDA Law Blog

OCTOBER 10, 2023

By Philip Won & Véronique Li, Senior Medical Device Regulation Expert — As we recently blogged , FDA released three draft guidance documents to help enhance the predictability, consistency, and transparency of the 510(k) program.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.”

Documentation 45

Documentation FDA Labelling Communication 45

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.

Communication 96

Communication Packaging Documentation Pharmaceutical Companies 96

Omnicell

JANUARY 10, 2023

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.

Omnicell 52

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. Is the vendors’ documentation complete in order to assess GxP risks and GxP compliance? and management communication strategy.

Documentation 98

Documentation FDA Labelling Communication 98