Japan's conditional early approval program for innovative cancer drugs: Comparison of the regulatory processes with the US FDA and the EMA.

Murayama, Anju; Ueda, Munetaka; Shrestha, Sunil; Tanimoto, Tetsuya; Ozaki, Akihiko

Murayama, Anju; Ueda, Munetaka; Shrestha, Sunil; Tanimoto, Tetsuya; Ozaki, Akihiko.

Affiliation

Murayama A; Medical Governance Research Institute, Minato-ku, Tokyo, Japan; Tohoku University School of Medicine, Sendai, Miyagi, Japan. Electronic address: ange21tera@gmail.com.
Ueda M; Medical Governance Research Institute, Minato-ku, Tokyo, Japan; Department of Orthopedic Surgery, Yokohama Rosai Hospital, Yokohama-shi, Kanagawa, Japan.
Shrestha S; School of Pharmacy, Monash University Malaysia, Jalan Lagoon Selatan, 47500, Bandar Sunway, Selangor, Malaysia.
Tanimoto T; Medical Governance Research Institute, Minato-ku, Tokyo, Japan; Department of Internal Medicine, Navitas Clinic Kawasaki, Kawasaki, Kanagawa, Japan.
Ozaki A; Medical Governance Research Institute, Minato-ku, Tokyo, Japan; Department of Breast Surgery, Jyoban Hospital of Tokiwa Foundation, Iwaki, Fukushima, Japan.

Cancer Cell ; 39(9): 1165-1166, 2021 09 13.

Article in En | MEDLINE | ID: mdl-34358449

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Full text: 1 Collection: 01-internacional Database: MEDLINE Main subject: Drug Approval / Legislation, Drug / Antineoplastic Agents Type of study: Observational_studies / Prognostic_studies Limits: Humans Country/Region as subject: America do norte / Asia Language: En Journal: Cancer Cell Journal subject: NEOPLASIAS Year: 2021 Document type: Article Country of publication: Estados Unidos

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