Farmakovijilans Derneği

FDA Draft Guidance for Pediatric Labeling.

The US Food and Drug Administration (FDA) has released a new draft guidance document pertaining to the pediatric information that sponsors and applicants must place within the approved product labelin

07 Temmuz, 2022

Detay

Three Drugs Added to FDA Watch List

Robert Lowes Feb 12, 2013 Administration (FDA) has added 3 drugs to its list of products to monitor because of possible signs of serious risks or new safety information.

07 Temmuz, 2022

Detay

Statins May Differ in Diabetogenic Potential

Feb 06, 2013 NEW YORK (Reuters Health) Feb 06 - The increased risk for new-onset diabetes with statin use differs by dose and agent, pooled data show. Compared with placebo

07 Temmuz, 2022

Detay

More on Lymphoma Risk from IBD Therapy

Immunomodulatory agents seem to be the principal culprits in raising the risk for lymphoma. Long-term therapy with thiopurines for inflammatory bowel disease (IBD) is associated with a several-fold i

07 Temmuz, 2022

Detay

Study Links Epilepsy Drug in Pregnancy to Lower IQ

WEDNESDAY Jan. 23, 2013 -- Children of mothers who take the antiepileptic drug valproate during pregnancy have lower IQ scores at age 6, a new study says. And the higher the dose of valproate during p

07 Temmuz, 2022

Detay

New EMA Guideline on the Investigation of drug Interactions

New EMA guideline on the investigation of drug interactions EMA has published a updated guideline on “Investigation of Drug Interactions.” Drug-drug interactions are a common problem during drug trea

07 Temmuz, 2022

Detay

13th ISoP Annual Meeting, Pisa 1-4 October 2013 - Updated Preliminary Programme

Dear colleagues and friends, we are pleased to announce that the updated version of the preliminary programme is now available on the conference website  http://www.isop2013pisa.org/preliminary-pro

07 Temmuz, 2022

Detay

Meeting Highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 1

PRAC recommendation on Diane 35 and generics The European Medicines Agency’s Pharmacovigilance Risk Assessment Committeehas concluded that the benefits of Diane 35 (cyproterone acetate 2 mg / ethiny

07 Temmuz, 2022

Detay