FDA Law Blog: Biosimilars

MARCH 7, 2024

Other Oversight Groups Both documents described the role of other oversight groups, in addition to DMCs, that may be involved in a clinical trial in similar, sometimes overlapping, roles such as IRBs, trial steering committees, and site monitors. Increased Connections Between a DMC and FDA?

Documentation 105

Documentation Adverse Reactions Communication Drug Development 105

RX Note

JULY 30, 2023

Adverse Drug Reactions The World Health Organization (WHO) defines an adverse drug reaction (ADR) as 'a drug-related event that is noxious and unintended and occurs at doses normally used in man for the prophylaxis, diagnosis or therapy of disease, or for modification of physiological function'. Is it safe?

Adverse Reactions 52

Adverse Reactions Patient Counseling Medical Records Documentation 52

FADIC

OCTOBER 20, 2023

■ All follow-up evaluations and interactions with the patient and his or her other healthcare professional should be included in MTM documentation. ■ Recognition of symptoms of adverse reactions and the appropriate procedures to follow. ■ Frequency of dose and administration time.   J Geriatr Cardiol.

Health and Personal Care Stores 52

Health and Personal Care Stores Documentation Medication Therapy Management (MTM) Medical Records 52

RX Note

FEBRUARY 23, 2023

G6PD Deficiency - Explaining G6PD Deficiency Ramadan - Medications during Ramadan fasting Adverse Drug Reactions Adverse Drug Reactions - All adverse reactions are adverse drug event Pharmacovigilance - To detect unreported ADRs Drug Allergy - Management vary based on the signs and symptoms Medicine-induced Discolouration - Red?

HIV Treatment and Prevention Agents 58

HIV Treatment and Prevention Agents Community Pharmacies Labelling Chemotherapy 58

The Thyroid Pharmacist

NOVEMBER 8, 2024

Fungal growth such as with mold can cause adverse reactions, inflammation, and impacts on immune health – and in turn, it can act as a trigger for asthma and autoimmune conditions, including Hashimoto’s. Fermented foods are also great, and are definitely one of my 12 favorite beneficial healing foods for the gut.

Immunity 68

Immunity Immunization Diabetes Adverse Reactions 68