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New EU trial regulations could expedite approvals and address shortages
New EU Clinical Trial Regulations simplify international trials while offering the means to counter drug shortages for trials ...
FDA cancels March meeting on flu vaccine composition without explanation
The FDA's decision to cancel the March meeting raises questions about flu vaccine guidance for manufacturers this year ...
Food Dive10h
FDA delays crackdown on which foods can be labeled ‘healthy’
The rule would prevent many cereal and yogurt products from making nutrition claims and allow nuts, oils and certain seafood ...
Viatris Falls to 52-Week Low; FDA Import Alert for India Facility Weighs on Guidance
Viatris shares fell to a 52-week low after the drug company said issues related to a India facility are expected to hurt 2025 total revenue by about $500 million. The stock was recently down 14% to $9 ...
India's drug regulator to streamline export process to reduce workload
India's drug regulator aims to implement various reforms, including streamlining export clearances for unapproved drugs and ...
JD Supra1d
FDA Delays Effective Date for Final Healthy Rule
On February 25, 2025, the U.S. Food and Drug Administration (FDA) delayed the effective date for its final “Healthy” rule from February 25, 2025 ...
BioWorld2d
FDA’s LDT rule, CDS guidance combine to complicate regulatory life
The routine use of software to interpret the results of lab-developed tests (LDTs) leaves clinical labs in a complicated spot in 2025 thanks in no small part to an ongoing lawsuit over the U.S. FDA’s ...
Food Processing2d
FDA Delays New ‘Healthy’ Definition and Rule To Comply With Trump Mandate
While it was set to become effective today (Feb. 25), the final rule is delayed until April 28, according to the Dept. of ...
Researchers helping to develop the first US guidelines for ADHD in adults
Thirty years ago, medical and psychological experts believed attention deficit hyperactivity disorder (ADHD) was a childhood ...
FDA delays when a final rule on what foods can be labeled as ‘healthy’ goes into effect
The FDA's new standards for foods before they can be labeled as "healthy" on their packaging will go into effect about two months later than planned.
The Express Tribune19d
FDA recalls 2 million baked goods over listeria risk
Under FDA guidelines, this classification is applied when consuming the product could lead to temporary or medically reversible health effects, while the risk of severe consequences remains low.
BioWorld22d
Accelerated approval, mRNA therapies in recent UK drug regulations
The U.K. is continuing to shape up regulation, adding reform of its accelerated drug approval process and its draft guidance on personalized mRNA cancer vaccines to new clinical trial regulations that ...