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In 2015, the government asked drug manufacturers to submit self-assessments to state authorities, but CDSCO said it hasn’t received any reports. Read More
Doctors may contact the FDA by phone, fax or email to seek approval for emergency use of an investigative drug, but a phone call is best after hours, the agency says, in a newly updated policy manual. Read More
Biocon said it plans to re-submit applications for European approval of two cancer-treatment biosimilars as soon as it corrects serious GMP deficiencies found at a Bangalore manufacturing plant. The company said it intends to fix the problems by Sept. 30. Read More