FDA’s Combo Product GMP Reg Speeds Ahead Unchanged
This article was originally published in The Gold Sheet
Agency decides to keep the proposed rule, issued in 2009, “largely identical” and denies requests to delay implementation a year.
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FDA's Office of Combination Products is also developing guidance on how to determine whether a medical product is a device, drug or biologic.
Agency's proposed "streamlined approach" to combination product manufacturing raises a number of practical questions, such as what elements are actual components of a combo product and at what stage the streamlined system kicks in, firms say.
US FDA proposed increasing staffing and resources for both programs during the next user fee program cycle, but industry representatives did not believe it necessary.