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Clissold — The trio of CDER, CBER, and CDRH released a new draft guidance titled “ Use of Data Monitoring Committees in Clinical Trials ” that revises the 2006 guidance “Establishment and Operation of Clinical Trial Data Monitoring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. That could be too high for some people ( JAMA , July 5, 2006 ). The FDA has established the maximum daily dose at 4,000 mg.

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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. This is because, with narrow therapeutic index drugs, small differences in the dose or blood concentration may lead to serious failure in therapy and possible adverse reactions that are life-threatening. Is a generic for Zoloft available?

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Department of Veterans Affairs Generic Medicine Insurance Adverse Reactions 52

The Checkup by Singlecare

JANUARY 23, 2024

Prescribing information for both probenecid and methotrexate mentions the risk of developing severe adverse reactions when these medications are taken concomitantly.

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Adverse Reactions Chemotherapy Communication Immunization 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 Thyroid Pharmacist

SEPTEMBER 1, 2023

Izuora 2011; Whyte 2006; USDA 2005). Who is Likely to Have an Adverse Reaction to Fluoride, and What are the Symptoms? As a result, tea drinks invariably contain high levels of fluoride. In the United States, brewed black tea averages about 3 to 4 ppm fluoride, while commercial iced tea drinks contain between 1 and 4 ppm.

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Compounding Adverse Reactions Chemotherapy Labelling 116

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. Sources Effects of oral corticosteroids on chronic warfarin therapy , The Annals of Pharmacotherapy (2006) Corticosteroids and ulcers: is there an association ?,

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Vaccines Mayo Clinic FDA Immunization 52