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FDA Issued Updated Patient-Focused Drug Development Guidance on Clinical Outcome Assessments

In its latest PFDD installment, the FDA offers a detailed roadmap for sponsors seeking to design, adapt, or validate COAs that accurately ...
Investor's Business Daily on MSN

Incyte stock rises on FDA breakthrough therapy fast track for rare blood cancer drug

The FDA granted Breakthrough Therapy status to Incyte's experimental treatment for a rare blood cancer. Incyte stock is basing near five-year highs.

Dog food company recalls 300 cases sold nationwide over plastic contamination fears

A major pet food recall affects BeefiBowls products sold nationwide. The company has implemented new safety measures ...

FDA’s top drug officer set to exit, weeks into new role

The US Food and Drug Administration’s longtime oncology chief has filed to retire from the agency just weeks after he was ...

Faulty glucose monitors linked to 7 deaths and more than 700 injuries, FDA warns

The U.S. Food and Drug Administration warned people to stop using certain types of glucose monitor sensors that were linked ...
STAT

FDA to lower number of trials required for approval of drugs, other medical products

The FDA plans to begin requiring one clinical study, instead of the standard two, for medical products before consideration ...

FDA chief says Biden administration withheld data on heart risk from Covid vaccines

Myocarditis is a known — but small — side effect of the mRNA Covid vaccines from Pfizer and Moderna, information that federal ...

US FDA removes longtime director of over-the-counter drugs office

The U.S. Food and Drug Administration is moving Theresa Michele, longtime director of the office of non-prescription drugs, ...

Don't let your dog chow on this! FDA recalls 300 cases of dog food due to contamination risk

Fromm Family Foods issued a recall of 300 cases of Bonnihill Farms BeefiBowls Beef Recipe due to potential foreign plastic ...

Dog food recalled in 14 states for plastic pieces that can harm pets

Check your latest pet food delivery: 300 cases of dog food have been recalled after they were found to be contaminated with ...
Food Safety News

Volumes of recalled food at both the FDA and FSIS have increased dramatically

At the same time, Food Safety and Inspection Service (FSIS) food recalls fell by 60.0 percent to just six events, down from ...

FDA approves topical cattle drug for screwworm, fever tick

The Exzolt Cattle-CA1 aka Fluralaner topical drug has received conditional approval from federal regulators to prevent and ...