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Clissold — The trio of CDER, CBER, and CDRH released a new draft guidance titled “ Use of Data Monitoring Committees in Clinical Trials ” that revises the 2006 guidance “Establishment and Operation of Clinical Trial Data Monitoring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

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FDA Documentation Adverse Reactions Communication 105

The People's Pharmacy

APRIL 10, 2023

Other Complications of NSAID Pain Medicine: Many of the other adverse reactions associated with NSAID pain medicine are not as obvious as digestive distress. The FDA has established the maximum daily dose at 4,000 mg. That could be too high for some people ( JAMA , July 5, 2006 ).

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Adverse Reactions Hospitals Labelling FDA 70

The Checkup by Singlecare

JULY 17, 2023

The generic form of Zoloft became available in 2006 and is a more affordable option. Food Drug Administration (FDA) , a generic medicine works in the same way and provides the same clinical benefit as brand-name medicine. The FDA Generic Drugs Program conducts a rigorous review to ensure generic drugs meet standards.

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Department of Veterans Affairs Generic Medicine Insurance Adverse Reactions 52

The Thyroid Pharmacist

SEPTEMBER 8, 2023

Or, you may invest in some supplements and medications, only to discover you have an adverse reaction to them. Or, you may even be scared to try a new intervention in case you have an adverse reaction to it. You may want to feel better and reclaim your life, but you may not know where to even start. Can you relate?

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Health and Personal Care Stores Adverse Reactions Compounding Immunization 98

The Checkup by Singlecare

OCTOBER 6, 2023

Many drug interactions are related to additive adverse reaction profiles with concomitant medications with similar side effect profiles. The interaction is severe enough that prescribing information for many NSAIDs warns against the concomitant use of corticosteroids in a Food and Drug Administration (FDA) issued Medication Guide.

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Vaccines Mayo Clinic FDA Immunization 52

The Thyroid Pharmacist

JULY 20, 2023

Some people may have adverse reactions to iron. 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] 2006 Feb 15;107(4):1673-9. [25] Dig Liver Dis. 25] Berger A.

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