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FDA Commissioner Scott Gottlieb once again chastised brand-name companies that slow-walk federal procedures and use regulations to delay the entry of generic competitors. Read More
In the coming year, the FDA’s top priorities will include broadening non-prescription access to drugs and updating compounder regulations, according to Commissioner Scott Gottlieb. Read More
Parts of the FDA’s recently updated draft guidance on the content and formatting of REMS documents are overly prescriptive, stakeholders said in public comments to the agency. Read More
“New drugs and vaccines are being brought to the market for the first time in public health programs in settings where the safety monitoring and regulatory systems need strengthening,” said MHRA’s CEO Ian Hudson. Read More
In a clinical trial, patients treated with lenvatinib along with everolimus lived approximately 10 months longer than those who took everolimus alone. Read More
The FDA issued draft guidance on when CDER may refuse to file new drug applications and biologics license applications, outlining errors or omissions that can lead them to classify the application as incomplete. Read More