The FDA Law Blog

MARCH 7, 2024

Clissold — The trio of CDER, CBER, and CDRH released a new draft guidance titled “ Use of Data Monitoring Committees in Clinical Trials ” that revises the 2006 guidance “Establishment and Operation of Clinical Trial Data Monitoring Committees” and, when final, will replace the 2006 guidance. Increased Connections Between a DMC and FDA?

FDA 105

FDA Documentation Adverse Reactions Communication 105

Omnicell

JANUARY 10, 2023

2006: Congress passed, and President George W. The investigation, which included inquiries requesting large amounts of documents and communications from various stakeholders, is largely perceived as a drug industry-friendly fact-finding exercise. 340B providers expressed significant concern.

Hospitals 96

Hospitals Omnicell Insurance Documentation 96

ISPE

MARCH 29, 2023

Concept Paper: M4Q(R2) Common Technical Document on Quality Guideline.” As part of the US Food and Drug Administration (FDA) QbD pilot 4 in 2005–2006, the need to convey how the control strategy is linked to the target product profile (TPP) and quality target product profile (QTPP) was discussed. The authors propose using Module 2.3

Documentation 52

Documentation Dosage Packaging Communication 52

ISPE

MARCH 29, 2023

Concept Paper: M4Q(R2) Common Technical Document on Quality Guideline.” As part of the US Food and Drug Administration (FDA) QbD pilot 4 in 2005–2006, the need to convey how the control strategy is linked to the target product profile (TPP) and quality target product profile (QTPP) was discussed. The authors propose using Module 2.3

Documentation 52

Documentation Dosage Packaging Communication 52

ISPE

MARCH 7, 2023

Company standards for various aspects of environmental sustainability should be defined in technical documents and procedures that complement Good Clinical Practice (GCP), Good Laboratory Practice (GLP), Good Manufacturing Practice (GMP), Good Distribution Practice (GDP), etc. 1 June 2006. 16 8 Medicines Agency.

Health and Personal Care Stores 52

Health and Personal Care Stores Pharmaceutical Companies Pharmaceutical Companies Communication 52

pharmaphorum

NOVEMBER 23, 2020

Through this outcomes measurement tool, patients keep comprehensive diaries of their condition, documenting what aspects of the disease affect them most. He joined Johnson & Johnson in 2001 as Director Corporate Communications. Daniel De Schryver is patient engagement & advocacy lead, Europe, Middle-East and Africa, at Janssen.

Communication 128

Communication Documentation Vaccines 128

ISPE

OCTOBER 28, 2022

The writing of requirements, design documentation, and test scripts, and the configuration of hardware and software, can be conducted from home. Audio-visual communication. Text communication. Technology and communications requirements. Technology and communication requirements. Table 3: Codes. Advantages.

Communication 52

Communication Documentation FDA 52