FDA Issues Its First Postmarketing Safety Reporting Regulations For Combination Products

The Food and Drug Administration (FDA) recently published a final rule setting forth the first postmarketing safety reporting regulations for combination products that have received FDA marketing authorization. Postmarketing Safety Reporting for Combination Products, 81(244) Fed. Reg. 92603-92626 (Dec. 20, 2016) (to be codified at 21 C.F.R. pt. 4) ("Final Rule"); see also 21 C.F.R. § 3.2(e) (defining "combination product" as, inter alia, a product comprised of two or more regulated components). The rule has an effective date of January 19, 2017, with some provisions requiring compliance on that date and others requiring compliance within eighteen months. Final Rule at 92603, 92619.

The new regulations are part of the FDA's ongoing effort to ensure the consistency and appropriateness of the regulatory requirements for combination products. Id. at 92603. Previously, the FDA applied postmarketing safety reporting regulations from one or more of the combination product's constituent parts. Id. at 92604. This led to inconsistent, incomplete, and duplicative reporting because the regulations for drugs, biological products, and devices differ from one another in their standards and timeframes. Id. The FDA intends the new regulations to ensure consistent, complete postmarketing safety reporting for combination products while avoiding duplicative reporting. Id. at 92604, 92606.

The new regulations do not constitute an entirely new reporting scheme for combination products, as proposed by some of the FDA's stakeholders. Id. at 92605. Instead, the regulations explain which of the existing postmarketing safety reporting regulations apply to combination product applicants (entities holding an application for a combination product) and constituent part applicants (entities holding an application for a drug, biological product, or device as a constituent part of a combination product where the other parts' applications are held by other entities). Id. at 92604; see also id. at 92624-25 (adding 21 C.F.R. §§ 4.100 and 4.101 to specify who is subject to the rule and to define certain terms).

Under the new regulations, combination product and constituent part applicants must comply with postmarketing safety reporting requirements corresponding to the type of application under which they received marketing authorization. Id. at 92604, 92605, 92607; see also id. at 92625 (adding 21 C.F.R. § 4.102(b)). Applicants who received authorization under a new drug...

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