NEWS

Dec 10,2017

Review of 41 New Drugs Approved by FDA in 2017

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Review of 41 New Drugs Approved by FDA in 2017

Dec 10,2017

Up to now, CDER has approved 41 new molecular entities, and the PDUFA deadline for 2 drugs falls in December. If FDA does not speed up the approval of new drugs in December, the number of new molecular entities approved in 2017 may be 41-43. Of course, the new drugs covered in this article are NDA or BLA accepted by CDER, and do not include CBER-reviewed varieties, such as CAR-T products. Compared with last year's 20 or so, this year is a bumper year. Of the 41 products that have been approved, 31 are approved for the first time in the world, 19 products have received priority review (P),13 have received breakthrough therapy certification (B),17 have received orphan drug qualification (O), and only 11 products except biological products are subject to standard review (O)

Key words:

Up to now, CDER has approved 41 new molecular entities, and the PDUFA deadline for 2 drugs falls in December. If FDA does not speed up the approval of new drugs in December, the number of new molecular entities approved in 2017 may be 41-43. Of course, the new drugs covered in this article are NDA or BLA accepted by CDER, and do not include CBER-reviewed varieties, such as CAR-T products. Compared with last year's 20 or so, this year is a bumper year. Of the 41 products that have been approved, 31 are approved for the first time in the world, 19 products have received priority review (P),13 have received breakthrough therapy certification (B),17 have received orphan drug qualification (O), and only 11 products except biological products are subject to standard review (O)

Dec 10,2017

Online sales of prescription drugs to open up hopeless pharmaceutical e-commerce or meet the "life and death robbery"

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Online sales of prescription drugs to open up hopeless pharmaceutical e-commerce or meet the "life and death robbery"

Dec 10,2017

China's pharmaceutical industry is in a new initial stage

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China's pharmaceutical industry is in a new initial stage

Dec 15,2017

Traditional Chinese medicine injection, unreasonable use magnifies the safety risk.

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Traditional Chinese medicine injection, unreasonable use magnifies the safety risk.

Dec 15,2017

Health Planning Commission: Chinese medicine clinics shall not provide western medicine and western medicine services.

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Health Planning Commission: Chinese medicine clinics shall not provide western medicine and western medicine services.
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