FDA published their recommendations for further testing if the result of a donor screening test for antibodies to the hepatitis C virus (anti-HCV) came out positive. These recommendations may be found in the draft guildeline on "Further Testing of Donations that are Reactive on a Licensed Donor Screening Test for Antibodies to Hepatitis C Virus".
Relating to the increasing need of simultaneously evaluatation of more than one investigational drug and/or more than one cancer type in one clinical trial, the FDA published a new guidance on Efficient Clinical Trial Design Strategies to Expedite Development of Oncology Drugs and Biologics.
The API manufacturer Keshava received a Warning Letter from the FDA in March 2018. During the inspection, it has been criticised that no corrective actions had been taken for Out-of-Specification results and that a few analyses missed complete data. Read more here about the FDA Warning Letter for Keshava Organics.