Updates by Reed Smith on U.S. legislative & regulatory developments affecting the health care industry
On June 12, 2103 the Food and Drug Administration (FDA) published a final rule amending the orphan drug regulations (21 CFR Part 316). The amendments are intended to clarify regulatory provisions and make minor improvements to address issues regarding orphan drug designation and orphan drug exclusivity.
The final rule largely finalizes the amendments as proposed…
In recent weeks, the Food and Drug Administration (FDA) has issued a number of new draft and final guidance documents on a range of issues, including financial disclosure by clinical investigators, medical device recalls, prescription drug labeling, and medical devices for pediatric uses. Highlights include the following:
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FDA has issued a final rule on the current good manufacturing practice (CGMP) requirements applicable to combination products. The rule clarifies which CGMP requirements apply when drugs, devices, and biological products are combined to create combination products. For certain types of combination products the application of CGMP requirements is straightforward – the constituent parts…
The FDA has announced the generic drug active pharmaceutical ingredient (API) and finished dosage form (FDF) facility user fee rates for fiscal year 2013. The API facility fee is owed by each person that owns a facility which produces, or which is pending review to produce, one or more APIs identified, or intended to…
The FDA has announced an opportunity for public comment on the statement of work for an assessment for the process of review of medical device submissions. Under the Medical Device User Fee Act of 2012 (MDUFA III), which gives FDA the authority to collect device user fees from industry for 2013-2017, FDA has committed to…
On January 2, 2013, the FDA issued three final guidance documents related to drug and medical device submissions. The first guidance, Acceptance and Filing Reviews for Premarket Approval Applications, is intended to clarify the criteria for accepting and filing a premarket approval application (PMA) to assure the consistency of FDA’s acceptance and filing decisions.…
The FDA released draft guidance on January 3, 2013 entitled Providing Regulatory Submissions in Electronic Format – Certain Human Pharmaceutical Product Applications and Related Submissions Using eCTD Specifications. The guidance is being issued in accordance with the Food and Drug Administration Safety and Innovation Act, which amended to Federal Food, Drug, and Cosmetic Act…
The FDA is seeking comments on draft guidance related to clinical trial enrichment: Enrichment Strategies for Clinical Trials to Support Approval of Human Drugs and Biological Products. The document is designed to provide guidance to industry on enrichment strategies that can be used in clinical trials intended so support effectiveness and safety claims in…
The FDA has released two final guidance documents intended to help sponsors and investigators comply with safety reporting requirements for IND applications and bioavailability (BA) and bioequivalence (BE) studies: Safety Reporting Requirements for INDs and BA/BE Studies, and Safety Reporting Requirements for INDs and BA/BE Studies – Small Entity Compliance Guide. Comments regarding both…
On April 29 and 30, 2013, the Food and Drug Administration (FDA) is hosting a public workshop on “Accessible Standardized Medical Device Labeling." The purpose of the event is to discuss the need for medical device labeling to be delivered in a clear, concise, and readily accessible format so that patients, caregivers, and healthcare…
On November 19, 2012, the Food and Drug Administration (FDA) published a notice and an amendment to a proposed rule related to FDA’s implementation of the FDASIA, which was signed into law on July 9, 2012. In the notice, FDA announced that it is seeking information from all stakeholders (including patients, physicians, dentists, and manufacturers) on appropriate uses of the custom device exemption identified in section 520(b) of the FDCA. By way of background, FDASIA amended section 520(b) of the FDCA, to (among other things) establish criteria for a device to qualify for a custom device exemption. Under section 520(b) of the FDCA as amended, “custom devices” are exempted from performance standard or premarket approval requirements if (among other things): (1) the device is “created or modified in order to comply with the order of an individual physician or dentist (or any other specially qualified person designated under regulations promulgated by the Secretary after an opportunity for an oral hearing)”; (2) the device is not “generally available in the United States in finished form through labeling or advertising by the manufacturer, importer, or distributor for commercial distribution”; (3) the device’s purpose is to treat a “unique pathology or physiological condition that no other device is domestically available to treat”; and (4) the device is manufactured for the “special needs of such physician or dentist (or other specially qualified person so designated) in the course of the professional practice of the physician or dentist (or other specially qualified person so designated)” or by an individual patient named in such order. Manufacturers are limited to using the custom device only for the purpose of treating a “sufficiently rare condition, such that conducting clinical investigations on such device would be impracticable.” Additionally, production of the device must be limited to no more than five units per year of a particular device type. Lastly, under section 617 of FDASIA, manufacturers will be required to submit an annual report explaining their use of the custom device exemption. Additional details are available after the break.
Continue Reading FDA Addresses Food and Drug Administration Safety and Innovation Act (FDASIA) Implementation
On December 19, 2012, the FDA is hosting a public meeting entitled “Framework for Pharmacy Compounding: State and Federal Roles” (the meeting also will be webcast). While the FDA acknowledges that “the States play a critical role in the oversight of traditional pharmacy compounding,” the FDA observes that “a category of “non-traditional” compounding has evolved…
On October 25, 2012, the Food and Drug Administration (FDA) published in the Federal Register the fiscal year (FY) 2013 rates for certain filings under the Generic Drug User Fee Program. Specifically, the notice establishes the new annual rates for an abbreviated new drug application (ANDA) ($51,520), prior approval supplement ($25,760), and drug master…
On September 24, 2012, the Food and Drug Administration (FDA) published two notices in connection with its patient-focused drug development initiative. The first notice announces a public meeting and an opportunity for public comment related to the initiative, and the second notice requests that patient stakeholders notify FDA of their intention to participate in periodic…
This post was written by Erin Janssen.
The FDA issued a final rule in August amending current regulations to reflect recent statutory amendments to the device registration and listing provisions of the FD&C Act. The Food and Drug Administration Amendments Act of 2007 (FDAAA), enacted on September 27, 2007, amended the FD&C Act…
This post was written by Erin Janssen.
The Food and Drug Administration (FDA) has announced the rates for biosimilar and prescription drug user fees for FY 2013. By way of background, the Federal Food, Drug, and Cosmetic Act (the FD&C Act) authorizes FDA to assess and collect user fees for certain activities in connection…
This post was written by Erin Janssen. On July 31, 2012, the FDA published the fee rates and payment procedures for medical device user fees for FY 2013. The fee rates apply from October 1, 2012 through September 30, 2013. To avoid delay in the review of an application, the fee should be…
This post was written by Erin Janssen.
On July 10, 2012, in response to requirements in legislation that passed Congress with broad bipartisan support, the Food and Drug Administration published a proposed rule that would require most medical devices distributed in the United States to carry a unique device identifier, or UDI, except…
FDA recently published a final rule that expands the scope of clinical investigator disqualification. Under the rule, when the FDA determines that an investigator is ineligible to receive one kind of test article (drugs, devices, or new animal drugs), the investigator also will be ineligible to conduct any clinical investigation that supports an application…
This post was written by Erin A. Janssen.
On May 3, 2012 the FDA issued its final rule on sterility testing, amending the requirements for most licensed biological products effective June 4, 2012. The rule is intended to promote improvement and innovation in the development of sterility test methods by allowing manufacturers the…
