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February 02, 2018
Manufacturers tackle regulatory and competitive issues to develop complex therapies and biosimilars.
February 01, 2018
The President described US drug costs as unfair and stated that prices will come down.
FDA Commissioner Scott Gottlieb says FDA is committed to meet the challenges faced by the saline shortage during an aggressive flu season.
CRLs put the brakes on drug development and damage corporate reputation and stock prices. Upfront investment and better sponsor oversight are ways to prevent them.
January 31, 2018
FDA and industry weigh broader use of prior knowledge in biotechnology testing and production.
January 24, 2018
The agencies sent warning letters to several companies that the agencies say are illegally marketing unapproved products to treat opioid addiction and withdrawal.
January 23, 2018
The latest continuing resolution funds the government for three weeks.
The FDA center released its list of planned guidance documents for the rest of the year.
The agency is sending a survey out to pharmaceutical companies in the UK to gain information on their preparedness for Brexit.
January 22, 2018
Non-essential activities and new regulatory submissions are on hold until a federal government funding agreement is reached.