Opening the FDA black box

Affiliations

Editorial

Steven N Goodman et al. JAMA. 2014 Jan.

. 2014 Jan;311(4):361-3.

doi: 10.1001/jama.2013.283946.

No abstract available

Comment on

Clinical trial evidence supporting FDA approval of novel therapeutic agents, 2005-2012.
Downing NS, Aminawung JA, Shah ND, Krumholz HM, Ross JS. Downing NS, et al. JAMA. 2014 Jan 22-29;311(4):368-77. doi: 10.1001/jama.2013.282034. JAMA. 2014. PMID: 24449315 Free PMC article.
Scientific and regulatory reasons for delay and denial of FDA approval of initial applications for new drugs, 2000-2012.
Sacks LV, Shamsuddin HH, Yasinskaya YI, Bouri K, Lanthier ML, Sherman RE. Sacks LV, et al. JAMA. 2014 Jan 22-29;311(4):378-84. doi: 10.1001/jama.2013.282542. JAMA. 2014. PMID: 24449316
FDA approval of cardiac implantable electronic devices via original and supplement premarket approval pathways, 1979-2012.
Rome BN, Kramer DB, Kesselheim AS. Rome BN, et al. JAMA. 2014 Jan 22-29;311(4):385-91. doi: 10.1001/jama.2013.284986. JAMA. 2014. PMID: 24449317 Free PMC article.