Central drug regulator creating guidelines for gene therapies, biosimilars: DCGI
Cell and gene therapies, which involve the transfer of genetic material or cells into a patient for treatment, have been on ...
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CA State Board of Pharmacy to vote on compounding regulations Mar. 6
The California State Board of Pharmacy (BOP) is poised to deny access to a long list of natural compounded medications that are vital to the health of tens of thousands of Californians, including ...
Could flu shot supply fall short this year? FDA's canceled meeting sparks worries
The FDA’s abrupt decision to cancel next month’s vaccine advisory committee meeting is raising concerns about whether the U.S ...
Pharmaceutical Technology6h
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 ...
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MAPS Releases Template to Assist in Federal Drug Sentencing Reform Efforts
In January, the U.S. Sentencing Commission announced proposed amendments to federal drug sentencing guidelines, including ...
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 Dive9h
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 ...
CDC recommends Covid vaccines for babies in new guidance that could anger health chief RFK Jr
The CDC today doubled down on its recommendation that babies should get the Covid vaccine, even after warnings over injuries ...
FDA Drags Heels on Vaccine Plans
The Department of Health and Human Services told Newsweek that it is "necessary to review agreements for vaccine production." ...
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 ...