The FDA Law Blog

JULY 7, 2024

Section IV, Additional Resources, provides links to previously-issued guidance documents and other educational materials geared to traditional device manufacturers, with no additional commentary on how to apply these requirements to the very different clinical laboratory environment. 803), Reporting of Corrections and Removals (21 C.F.R. §

Labelling 64

Labelling FDA Communication Documentation 64

European Pharmaceutical Review

DECEMBER 19, 2023

7 The additional substantial economic benefits that flow from room-temperature storability have also been thoroughly documented. This requires the development of technologies to rapidly produce effective, safe, stable vaccines that can be manufactured and distributed quickly. Internet] WHO. cited 2023July]. Available from: [link] WHO.

Vaccines 111

Vaccines Communication Immunization Documentation 111

ISPE

OCTOBER 27, 2022

Wireless medical devices use wireless radio frequency communication such as wifi, Bluetooth, and cellular/mobile phone technology. Is the software performing an action on data different from storage, archival, communication, or simple search? Global Strategy on Digital Health 2020-2025.” Wireless medical devices.

Health and Personal Care Stores 52

Health and Personal Care Stores FDA Communication Clinic Management 52

Hospital Pharmacy Europe

JANUARY 6, 2025

The Oral Cancer Therapy Initiative provides community and hospital pharmacists with essential information about cancer drugs, side effects and adherence, while patients are given tools to document their experiences and facilitate better communication with the healthcare professionals they come into contact with throughout the system.

Community Pharmacies 98

Community Pharmacies Vaccines Hospitals Documentation 98

ISPE

OCTOBER 27, 2022

Wireless medical devices use wireless radio frequency communication such as wifi, Bluetooth, and cellular/mobile phone technology. Is the software performing an action on data different from storage, archival, communication, or simple search? Global Strategy on Digital Health 2020-2025.” Wireless medical devices.

Health and Personal Care Stores 52

Health and Personal Care Stores FDA HIPAA Communication 52

The FDA Law Blog

JULY 9, 2024

Procedures for Submitting the DAP Sponsors should describe the DAP clearly and concisely, with limited cross-referencing to previously submitted documents. If FDA determines that a waiver will be issued, it may consider public communications about the decision. Some unanswered questions remain.

FDA 59

FDA Communication Documentation Labelling 59

ISPE

SEPTEMBER 11, 2023

Nature Communications 12, no. Subsequently, the new data is authored into Module 3 (Quality) of the Common Technical Document and submitted separately to multiple health authorities worldwide for approval. Biotechnology Progress 36, no. 3 (2020):e2970. 34 Maschan, M., 1 (2021):7200. 35 Anguille, S., 36 Sterling, J. 22 March 2018.

Health and Personal Care Stores 52

Health and Personal Care Stores Vaccines Packaging Documentation 52

PQA

SEPTEMBER 28, 2022

Food security challenges disproportionately impact underserved communities, including communities of color, people living in rural areas, people who are differently-abled, older adults, LGBTQI+ people, military families, and military veterans.

Documentation 52

Documentation Communication 52

PQA

NOVEMBER 26, 2024

In documentation of the care provided, the MTP Categories Framework promotes consistent identification of MTPs found and the interventions taken to resolve MTPs within MTM services. It is clear to me that this rational approach is vital for practice standardization and documentation. Applications for 2025 are due December 13, 2024.

Patient Care 52

Patient Care Documentation Communication 52

The FDA Law Blog

FEBRUARY 5, 2025

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

Documentation 95

Documentation FDA Labelling Communication 95

European Pharmaceutical Review

APRIL 14, 2025

In the UK, the Human Medicines (Amendment) (Modular Manufacture and Point of Care) Regulations 2024 1 have passed through the UK legislative procedure and will apply from 23 July 2025. Master file the manufacturing dossier in which the main regulatory documents are collected and to which all subordinate sites refer.

Hospitals 52

Hospitals Documentation Insurance Packaging 52