• Hypertrophic Cardiomyopathy (HCM)
  • Vaccines: 2023 Year in Review
  • Eyecare
  • Urothelial Carcinoma
  • Women's Health
  • Hemophilia
  • Heart Failure
  • Vaccines
  • Neonatal Care
  • NSCLC
  • Type II Inflammation
  • Substance Use Disorder
  • Gene Therapy
  • Lung Cancer
  • Spinal Muscular Atrophy
  • HIV
  • Post-Acute Care
  • Liver Disease
  • Biologics
  • Asthma
  • Atrial Fibrillation
  • RSV
  • COVID-19
  • Cardiovascular Diseases
  • Prescription Digital Therapeutics
  • Reproductive Health
  • The Improving Patient Access Podcast
  • Blood Cancer
  • Ulcerative Colitis
  • Respiratory Conditions
  • Multiple Sclerosis
  • Digital Health
  • Population Health
  • Sleep Disorders
  • Biosimilars
  • Plaque Psoriasis
  • Leukemia and Lymphoma
  • Oncology
  • Pediatrics
  • Urology
  • Obstetrics-Gynecology & Women's Health
  • Opioids
  • Solid Tumors
  • Autoimmune Diseases
  • Dermatology
  • Diabetes
  • Mental Health

Drug approvals slow down

Article

Washington, D.C.-Pressure to uncover potential adverse events before a new drug reaches patients seems to be taking a toll on drug development and marketing. The Food and Drug Administration (FDA) approved only 19 innovative new drugs in 2007, according to preliminary analyses. That's way down from the peak of 53 new drugs in 1996, but in line with a steady decline in new drug approvals since 2002.

Pharmaceutical companies believe this trend reflects a "new environment" at FDA that has raised the bar for new drug approvals. FDA reviewers routinely request additional studies, according to R&D executives, and delays in launching new products are common. One industry response is to seek more new indications for existing medicines, particularly expensive biologics. FDA officials claim that they have not changed standards, but have become better at detecting safety problems, especially for drugs to treat chronic conditions.

Related Videos
Related Content
© 2024 MJH Life Sciences

All rights reserved.