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FDA Releases Fourth Biosimilar Guidance Outlining New Types of Meetings

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The US Food and Drug Administration (FDA) has released a fourth and long-anticipated draft guidance document pertaining to the regulatory pathway for biosimilar products, this time on how sponsors Read More...

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Biosimilars

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Follow-on Biologic

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Similar Biological Product

Legislative Amendment Could Affect FDA's Ability to Meet with Industry

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Even if it had the funding to do so, the US Food and Drug Administration (FDA) may soon find itself unable to send too many of its employees to some meetings if an amendment to a pending budget bill Read More...

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Tom Coburn

Draft Guidance Increases FDA Flexibility During Interactive Reviews of Medical Device Submissions

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The US Food and Drug Administration (FDA) has released a new draft guidance for industry intended to clarify the types of communication used during the review of medical device product submissions Read More...

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EMA Announces Huge Overhaul of Operations, Processes

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The European Medicines Agency (EMA) is preparing to reorganize its operations, processes and offices in 2013, it has announced.In a statement released on its website on 19 December 2012, the agency Read More...

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CHMP

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HMPC

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PDCO

PRAC

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Changes Coming to Medical Device Pre-submission Meeting Program

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The US Food and Drug Administration (FDA) has released new draft guidance for medical device manufacturers looking to meet with the agency in advance of submitting a wide range of device Read More...

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European Regulator Cancels, Postpones Meetings in Face of Traffic

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Of all the contingencies planned for by regulatory professionals, sporting events seem to be rare among the potentialities meriting discussion. But European-based regulatory professionals planning on Read More...

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Paper: Small Companies Need Regulatory Assistance from EMA

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The European Medicines Agency (EMA) needs to assist companies—particularly small businesses, academic institutions and charities—in the development of advanced-therapy medicines, claims a new paper Read More...

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RF Today is Regulatory Focus' daily news brief. Each edition contains the top global regulatory news stories about pharmaceuticals, medical devices, biotechnology and more. Learn more

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FDA Releases Fourth Biosimilar Guidance Outlining New Types of Meetings

Legislative Amendment Could Affect FDA's Ability to Meet with Industry

Draft Guidance Increases FDA Flexibility During Interactive Reviews of Medical Device Submissions

EMA Announces Huge Overhaul of Operations, Processes

Changes Coming to Medical Device Pre-submission Meeting Program

European Regulator Cancels, Postpones Meetings in Face of Traffic

Paper: Small Companies Need Regulatory Assistance from EMA

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