FDA Law Blog: Biosimilars

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Clissold — The trio of CDER, CBER, and CDRH released a new draft guidance titled “ Use of Data Monitoring Committees in Clinical Trials ” that revises the 2006 guidance “Establishment and Operation of Clinical Trial Data Monitoring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?

Documentation 105

Documentation Adverse Reactions Communication Drug Development 105

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

Putting Patients First Blog

APRIL 30, 2024

Key Points of Support Conciseness and Focus of Key Information The NHC supports the FDA’s emphasis on beginning the informed consent document with concise, focused presentations of key information. Clarity in communication is not just about convenience; it is a fundamental aspect of ethical medical practice and research.

Documentation 52

Documentation Communication Mayo Clinic Drug Development 52

Integra X Files

DECEMBER 19, 2022

The Medicare Prescription Drug Benefit was passed into law nearly 20 years ago (2003) and implemented in 2006. The document also requires plans to provide a transition period for non-formulary drugs to ensure beneficiaries have continuous access to required medications.

Nursing Homes 52

Nursing Homes Documentation Dosage Packaging 52

The Thyroid Pharmacist

JUNE 14, 2023

Both our sex and thyroid hormones are part of an overall hormone communications network in our body, referred to as the HPA (Hypothalamic-Pituitary-Adrenal) axis. A 2015 case report documented the thyroid labs of a man who had recurrent hyperthyroid episodes after three of his wife’s pregnancies! His wife had Hashimoto’s.)

Health and Personal Care Stores 111

Health and Personal Care Stores Immunization Immunity Documentation 111

The Thyroid Pharmacist

JANUARY 20, 2023

Holy Basil ( Ocimum sanctum ) The anti-inflammatory effects of holy basil (also known as tulsi) have been documented in many in vitro and in vivo studies. 2006 Feb 16;78(12):1287-92. Please do consult with your doctor when taking any new supplements; this is especially true for one with so many contraindications. Int J Ayurveda Res.

HIV Treatment and Prevention Agents 98

HIV Treatment and Prevention Agents Diabetes Immunization Immunity 98