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February 02, 2018
Drug manufacturers can improve use of quality agreements in contract manufacturing.
February 01, 2018
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 23, 2018
The latest continuing resolution funds the government for three weeks.
January 22, 2018
Non-essential activities and new regulatory submissions are on hold until a federal government funding agreement is reached.
January 16, 2018
The US Government Accountability Office released a report stating that FDA should make its plans to release guidance regarding nonbiological complex drugs public.
The agency has expanded the indication of AstraZeneca’s anti-cancer drug to include treatment for breast cancer with a certain inherited genetic mutation.
January 05, 2018
FDA noted in a recent inspection that American CryoStem was receiving and processing adipose tissue into a product called Atcell, and then marketing the product without agency approval.
January 03, 2018
The agency published draft guidance on good practices for submitting abbreviated new drug applications.
January 02, 2018
FDA looks to achieve near-record level of new drug approvals following slowdown in 2016.
Bio/pharma professionals manage expectations amid industry uncertainty.