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The FDA is soliciting comments from industry members and shareholders on how direct-to-consumer drug advertising should depict risk information. Read More
A company that warehouses drugs but doesn’t own them fits into a new category to be regulated under a 2013 federal law that aims to tighten security over the drug supply chain by 2023, according to new FDA guidance released Aug. 18. Read More
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