Breastfeeding is not recommended when using codeine or tramadol

Aug 01 - Serious and sometimes fatal side effects may occur in some infants

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A discussion of trending data quality issues in drug review

Aug 22 - Resolving issues with Standards for Exchange Nonclinical Data (SEND)

Updated: Clinical Outcome Assessment (COA) Compendium

Aug 21 - Encouraging the use of patient-focused COAs in clinical trials

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Attend the Pediatric Advisory Committee meeting

Aug 20 - Submit your views on opioids, Singulair use for pediatric patients

Drug Information, Safety, and Availability

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Opioids

Reducing the impact of opioid misuse and abuse

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Director's Corner

CDER Center Director Dr. Janet Woodcock speaking on drug-related topics

Aug 13

FDA review finds no increased risk of prostate cancer with Parkinson's disease medicines containing entacapone (Comtan, Stalevo)

Jul 26

FDA approves Boxed Warning about increased risk of blood clots and death with higher dose of arthritis and ulcerative colitis medicine tofacitinib (Xeljanz, Xeljanz XR)

Jul 24

FDA Updates and Press Announcements on Angiotensin II Receptor Blocker (ARB) Recalls (Valsartan, Losartan, and Irbesartan)

Drug Safety Announcements

Center

Aug 14

Pfizer Inc. Issues a Voluntary Nationwide Recall for 2 Lots of RELPAX® (eletriptan hydrobromide) 40 mg Tablets Due to Potential Microbiological Contamination of Non-Sterile Products

Aug 08

Ridge Properties LLC DBA Pain Relief Naturally Issues Voluntary Nationwide Recall of PRE-TAT , Superior Pain and Itch Relief, and Soothing Sore Relief Cream and Gel Products Due to Microbiological Contamination and Superpotency

Jul 24

Herbal Doctor Remedies Issues Voluntary Nationwide Recall of All Drug Products Due to Marketing Without FDA Approval and Concerns with Manufacturing Practices

Center

Aug 20

FDA warns company for putting consumers at risk with drug manufacturing data integrity violations

Aug 19

FDA approves new antibiotic to treat community-acquired bacterial pneumonia

More Press Announcements

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