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Clissold — The trio of CDER, CBER, and CDRH released a new draft guidance titled “ Use of Data Monitoring Committees in Clinical Trials ” that revises the 2006 guidance “Establishment and Operation of Clinical Trial Data Monitoring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

Documentation 104

Documentation FDA Adverse Reactions Communication 104

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?

Department of Veterans Affairs 52

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.

Adverse Reactions 52

Adverse Reactions Chemotherapy Communication Immunization 52

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.

Adverse Reactions 70

Adverse Reactions Hospitals Labelling Compounding 70

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 ?,

Vaccines 52

Vaccines Mayo Clinic FDA 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?

Health and Personal Care Stores 98

Health and Personal Care Stores Adverse Reactions Compounding Immunization 98

The Thyroid Pharmacist

JULY 8, 2022

If you do have an adverse reaction to selenium (again, this is very rare), you may find that you have an iodine deficiency. That said, I have heard from a few clients and readers that adding selenium in the presence of low iodine levels has made them feel worse. The Journal of Clinical Endocrinology and Metabolism. doi: 10.1210/jc.2006-1821.

Dosage 59

Dosage Immunization Adverse Reactions Insurance 59