Drugindustrydaily

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Feb. 15, 2019

Vol. 18
No. 32

Headlines

Editor’s Note

In observance of Presidents' Day, Drug Industry Daily will not be published Monday, Feb. 18. The next issue will be published Tuesday, Feb. 19. Read More

Spending Bill Gives FDA $269 Million Increase for Fiscal 2019

A bipartisan appropriations bill for fiscal 2019 that would give the FDA $269 million more than in fiscal 2018 passed in the Senate and House on Thursday and is expected to be signed into law by the president. Read More

FDA Announces Pilot Program for CMC Changes

The FDA is seeking participants for a pilot program to help the agency define specific established conditions (ECs) for chemistry, manufacturing and controls in applications for NDAs, ANDAs and BLAs. Read More

House E&C Committee Calls for FDA Briefing on Sartan Recalls, Foreign Inspections

Members of the House Energy and Commerce Committee sent a letter to FDA Commissioner Scott Gottlieb on Wednesday calling for a briefing on the ongoing recalls of sartan blood pressure drugs and on the agency’s foreign inspections. Read More