The FDA Law Blog

JANUARY 4, 2023

As previously m entioned , sponsors can interact with FDA in the town hall by submitting questions in advance or by asking a question live during the meeting. The Agency repeatedly stated and strongly recommends sponsors engage with FDA prior to submitting the IND. The workshop is also discussed in Cell & Gene here and here.

FDA 59

FDA Labelling 59

ISPE

JULY 19, 2023

™ started in 2015 at the ISPE Germany/Austria/Switzerland (D/A/CH) “Plug and Produce” workshop in Basel, Switzerland. ™, driven by the recognition that digital transformation offers a big chance to finally realize the US FDA’s Pharmaceutical Quality for the 21st Century Initiative to the full extent. to a pharma-specific Pharma 4.0™

Documentation 98

Documentation FDA Communication Labelling 98

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.

FDA 59

FDA Documentation Labelling 59

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In December 2021, the US FDA issued a cross-center draft guidance with recommendations on the use of digital health technology tools (DHTTs) to acquire data remotely from participants in clinical investigations for medical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

Health and Personal Care Stores 52

Health and Personal Care Stores FDA Communication Clinic Management 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In December 2021, the US FDA issued a cross-center draft guidance with recommendations on the use of digital health technology tools (DHTTs) to acquire data remotely from participants in clinical investigations for medical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.

Health and Personal Care Stores 52

Health and Personal Care Stores FDA HIPAA Communication 52

The Thyroid Pharmacist

JULY 20, 2023

Just this year, the FDA approved Jesduvroq tablets (daprodustat) as the first oral treatment for anemia caused by chronic kidney disease, for adults who have been receiving dialysis for at least four months. [58] Nestle Nutr Workshop Ser Pediatr Program. A reinvestigation using Fe-labelling and non-invasive liver iron quantification.

Health and Personal Care Stores 95

Health and Personal Care Stores HIV Treatment and Prevention Agents Insurance Immunization 95