Pharmaceutical Technology

JUNE 1, 2023

Additionally, when asked whether the FDA should consider a potential accelerated approval, panellists voted 15 to one against that regulatory pathway for the drug. Additionally, when asked whether the FDA should consider a potential accelerated approval, panellists voted 15 to one against that regulatory pathway for the drug.

FDA 52

FDA Documentation 52

The FDA Law Blog

OCTOBER 5, 2022

By Riëtte van Laack — On September 28, 2022, FDA announced the availability of the proposed rule for the implied nutrient content claim “healthy.” The term healthy, as an implied nutrient claim, was first defined by FDA in 1994. FDA also announced it would be re-evaluating the regulatory criteria for use of the “healthy” claim.

FDA 52

FDA Labelling Packaging Documentation 52

The FDA Law Blog

OCTOBER 24, 2023

Mullen — As of October 1, 2023, all 510(k) submissions, unless exempted, must be submitted to FDA using the electronic Submission Template And Resource ( eSTAR ). Currently, eSTAR is voluntary for medical device De Novo submissions, but FDA has initiated the process of requiring De Novos to be submitted using eSTAR.

FDA 52

FDA Documentation Labelling 52

The FDA Law Blog

JUNE 21, 2023

Background – Strategic Priority to Advance Health Equity In CDRH’s 2022-2025 Strategic Priorities , “Advance Health Equity” is listed as one of the three strategic priorities along with “Promote a Modern and Diverse Workforce” and “Enhance Organizational Agility and Resilience.”

Documentation 45

Documentation FDA Patient Care Hospitals 45

ISPE

NOVEMBER 2, 2022

Strategic plan refresh for 2023–2025 involved an adaptation from the existing strategic plan, with the Society taking a “very confident position: Shaping the Future of Pharma and bringing quality medicines to patients worldwide.”. Expenses for documents and conferences have been higher this year.

Documentation 52

Documentation Compounding Communication FDA 52

ISPE

OCTOBER 27, 2022

In December 2021, the US FDA issued a cross-center draft guidance with recommendations on the use of digital health technology tools (DHTTs) to acquire data remotely from participants in clinical investigations for medical products. Table 3: Example classification of DHTs. .

Health and Personal Care Stores 52

Health and Personal Care Stores FDA Communication Clinic Management 52

The FDA Law Blog

JANUARY 23, 2023

Livornese — Last month, Congress took a big step towards improving clinical trial diversity by requiring sponsors of most drug and device clinical studies to submit a diversity action plan when they submit key trial documents to the Food and Drug Administration (FDA). This guidance was finalized in 2020. by the end of 2023).

FDA 59

FDA Documentation Labelling 59