Results 131 to 140 of about 5,946 (190)

Emerging Isseus in FDA Regulation: Warning Letters, Internet Promotion, and Tobacco [PDF]

, 2010
Senger, Jeffrey M.
core  

Identifying Pediatric Drug Safety Knowledge Gaps: An Integrated Approach Leveraging Real-World Data, a Biomedical Knowledge Base, and Postmarketing Surveillance Data. [PDF]

Pharmacotherapy
Rahurkar S, Ouyang J, Jonnalagadda P, Liu X, Zhang S, Chiang CW, Wang L, Shendre A, Li L.   +8 more
europepmc   +1 more source

Peri-procedural and 6-month outcomes of rotational atherectomy for highly calcified femoropopliteal lesions from Japanese postmarketing surveillance. [PDF]

Heart Vessels
Soga Y, Urasawa K, Tsujimura T, Yamamoto Y, Fujihara M, Nakama T, Haraguchi T, Tobita K.   +7 more
europepmc   +1 more source

Navigating hepatotoxicity of antibody-drug conjugates: from mechanistic insights to clinical and postmarketing evidence. [PDF]

Front Pharmacol
Dong Y, Zhi Y, Li X, Ma M, Ye M, Huang S, Tang J, Zhong W, Lei X, Mao Y.   +9 more
europepmc   +1 more source

Brief of Amici Curiae Former FDA Commissioners Dr. Donald Kennedy and Dr. David A. Kessler in Support of Respondent, Wyeth v. Levine, No. 06-1249 (U.S. Aug. 14, 2008) [PDF]

, 2008
Sabbeth, Kathryn A., Vladeck, David C.
core   +1 more source

Real-world evaluation of interstitial lung disease/pneumonitis in patients treated with trastuzumab deruxtecan for HER2-positive advanced or recurrent gastric cancer: a postmarketing surveillance study in Japan. [PDF]

ESMO Open
Kawakami H, Uchino K, Hashimoto W, Muro K.   +3 more
europepmc   +1 more source

Comprehensive post-marketing safety evaluation of atezolizumab: A disproportionality analysis based on individual case safety reports in the FAERS. [PDF]

PLoS One
Cui Y, Gao Y, Meng N, Li X, Zhao N, Yu L.   +5 more
europepmc   +1 more source

Real-world safety and effectiveness of alemtuzumab for relapsed or refractory chronic lymphocytic leukaemia: results from postmarketing surveillance in Japan. [PDF]

Jpn J Clin Oncol
Sasakura Y, Hatanaka M, Ishizawa K.
europepmc   +1 more source

Risk of severe infections in patients with triple-negative breast cancer treated with atezolizumab plus nab-paclitaxel: a real-world, postmarketing database study in Japan. [PDF]

Int J Clin Oncol
Yuri A, Nakane S, Miyano Y, Yamada K, Sugano H, Nakatsuji E, Aoki M, Murayama A.   +7 more
europepmc   +1 more source

Clinical Characteristics and Safety Profiles of Japanese Psoriasis Patients Who Continued Apremilast Treatment for 6 and 12 Months: A Post Hoc Analysis of an Apremilast Postmarketing Surveillance Study. [PDF]

J Dermatol
Ohtsuki M, Okubo Y, Saeki H, Igarashi A, Imafuku S, Abe M, Saito K, Ogawa R, Morita A.   +8 more
europepmc   +1 more source