Health Industry Washington Watch : Washington DC Healthcare Industry Law Firm : Reed Smith : Health Industry Washington Watch : Regulations, Medicare/Medicaid, Governmental Organizations

This post was written by Jennifer Pike.

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:

• Financial Disclosure by Clinical Investigators. This final guidance assists in interpreting and complying with regulations governing financial disclosure by clinical investigators. It provides FDA’s responses to the most frequently-asked questions regarding financial disclosure by clinical investigators.
• Distinguishing Medical Device Recalls from Product Enhancements: Reporting Requirements. This draft guidance clarifies when a potential change to a device is a medical device recall, distinguishes those instances from product enhancements, and identifies the reporting requirements for both recalls and product enhancements.
• Labeling for Human Prescription Drug and Biological Products: Implementing the PLR Content and Format Requirements. This final guidance is intended to assist applicants in complying with the content and format requirements of labeling for human prescription drug and biological products under the Physician Labeling Rule (PLR). It provides recommendations for applicants developing labeling for new prescription drugs and revising labeling for already approved prescription drugs.  
• Providing Information about Pediatric Uses of Medical Devices under Section 515A of the Federal Food, Drug, and Cosmetic Act (FFDCA). This draft guidance describes how to compile and submit the readily-available pediatric use information required under the FFDCA.

• Print
• Comments
• Trackbacks
• Share Link

This post was written by Jennifer Pike.

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 of a combination product are each subject only to the CGMP requirements applicable to that type of constituent part if the parts are manufactured and marketed separately. In other words, where parts of a combination product are separately manufactured and marketed, they remain separate for the purposes of applying CGMP regulations. The application of CGMP requirements to “single-entity” and “co-packaged” combination products is more complex. Thus, the final rule also sets forth a transparent and streamlined regulatory framework for manufacturers to use when demonstrating compliance with CGMP requirements for such products. Specifically, manufacturers may demonstrate compliance with CGMPs for “single-entity” and “co-packaged” combination products in one of two ways: (1) by demonstrating compliance with the specifics of all CGMP requirements applicable to each of the constituent parts included in the combination product; or (2) if the combination product contains both a drug and a device, demonstrating compliance with either drug CGMPs or quality system regulations for devices, in addition to other requirements set forth in the final rule. “Single-entity” combination products are products comprised of two or more regulated components that are physically, chemically, or otherwise combined or mixed and produced as a single-entity. “Co-packaged” combination products are two or more separate products packaged together in a single package or as a unit and comprised two regulated components. The rule becomes effective on July 22, 2013.

• Print
• Comments
• Trackbacks
• Share Link

This post was written by Jennifer Pike.

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 be identified, in at least one generic drug submission that is pending or approved or in a Type II API master file referenced in such generic drug submission. The API facility fee for 2013 for domestic facilities is $26,458, while the API facility fee for foreign facilities is $41,458. The FDF facility fee is owed by each person that owns a facility which is identified or is intended to be identified, in at least one generic drug submission that is pending or approved, to produce one or more finished dosage forms of the human generic drug. The FDF facility fee for 2013 for domestic facilities is $175,389, and the FDF facility fee for foreign facilities is $190,389. Both API and FDF fees are due on March 4, 2013. FDA is authorized to collect these fees, among others, under the Generic Drug User Fee Amendments of 2012.

• Print
• Comments
• Trackbacks
• Share Link

This post was written by Jennifer Pike.

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 reaching certain performance goals. Among others, FDA is committed to participate, with the device industry, in a comprehensive assessment of the process for the review of device applications. The assessment will be conducted in two phases by a private, independent contractor. FDA is providing a comment period on the statement of work before requesting proposals for the assessment. Comments should be submitted in writing or electronically, at www.regulations.gov, by February 4, 2013.

• Print
• Comments
• Trackbacks
• Share Link

This post was written by Jennifer Pike.

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 guidance is applicable to original PMAs and PMA panel-track supplements reviewed by the Center for Devices and Radiological Health (CDRH) and the Center for Biologics Evaluation and Research (CBER). The second guidance, eCopy Program for Medical Devices Submissions, explains the new electronic copy (eCopy) Program for medical devices submissions, provides the standards for a valid eCopy, and identifies the submission types that must include an eCopy in accordance with such standards for the submission to be processed and accepted for review by FDA. The final guidance, Refuse to Accept Policy for 510(k)s, explains the procedures and criteria FDA intends to use in determining whether a 510(k) submission is administratively complete. The guidance is applicable to 510(k)s reviewed by CDRH and CBER.Comments regarding the guidances may be submitted at any time.

• Print
• Comments
• Trackbacks
• Share Link

This post was written by Jennifer Pike.

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 to require that certain regulatory submissions be submitted in electronic format. The guidance describes how FDA plans to implement this requirement. According to the guidance, requirements for electronic submission will be phased in on the following schedule: (1) 24 months after publication of the final version of this draft guidance, the requirements will apply to new drug application (NDA), abbreviated new drug application (ANDA), and biologics license application (BLA) submissions, and (2) 36 months after publication of the final guidance, the requirements will apply to investigational new drug application (IND) submissions. Comments will be accepted until March 4, 2013. A second draft guidance document, Providing Submissions in Electronic Format – Summary Level Clinical Site Data for CDER’s Inspection Planning, is intended to assist applicants in the voluntary submission of a clinical dataset that describes and summarizes the characteristics and outcomes of clinical investigations at the individual study site level. Such datasets facilitate the use of a risk-based approach to timely identification of clinical investigator sites for onsite inspection by FDA during the review of marketing applications. The guidance describes a recommended electronic format for the datasets to be submitted voluntarily in NDA, BLA, and NDA and BLA supplemental applications submitted to CDER. Comments may be submitted to www.regulations.gov by February 19, 2013.

• Print
• Comments
• Trackbacks
• Share Link

This post was written by Jennifer Pike.

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 NDAs and BLAs. According to FDA, enrichment could lead to smaller studies, lower development costs, and help develop more personalized medicine. The guidance defines and discusses three types of enrichment strategies: decreasing heterogeneity, predictive enrichment, and prognostic enrichment. The guidance also discusses general clinical trial design considerations, provides examples of various potential clinical trial designs, and discusses potential regulatory considerations when using enrichment strategies in clinical trials. Comments may be submitted at www.regulations.gov until February 15, 2013.

• Print
• Comments
• Trackbacks
• Share Link

This post was written by Jennifer Pike.

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 guidance documents may be submitted at any time.

• Print
• Comments
• Trackbacks
• Share Link

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 providers may use device labeling as efficiently and effectively as possible. This public workshop aims to engage stakeholders in active discussion with FDA and to encourage public comments regarding standard content and format for medical device labeling and the use of a repository containing medical device labeling. FDA also is accepting written or electronic comments related to the public workshop; comments will be accepted until April 12, 2013.

• Print
• Comments
• Trackbacks
• Share Link

This post was written by Jennifer Pike.

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.

• Print
• Comments
• Trackbacks
• Share Link

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 in the last decade that FDA believes requires additional oversight.” According to the notice, the FDA is working with Congress to consider new authorities regarding these “non-traditional” compounding pharmacies. In addition to holding the public meeting, the FDA is soliciting comments on several specific questions related to federal and state roles in the regulation of pharmacy compounding, such as (1) whether the states currently are able to provide oversight of pharmacy compounding and consumer protection; (2) what the federal role should be in regulating higher risk pharmacy compounding such as compounding high-volumes of drugs for interstate distribution; and (3) whether or not there is a role for the states in enforcing a federal standard for "nontraditional" compounding. Comments are due by January 18, 2013.

• Print
• Comments
• Trackbacks
• Share Link

This post was written by Jennifer Pike.

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 file ($21,340). These fees are effective on October 1, 2012 and remain in effect through September 30, 2013. The fees for the ANDA and prior approval supplement are due by the applicant on the date of submission, or 30 days after the published notice (i.e. November 24, 2012), whichever is later. The drug master file (DMF) fee is owed by each person that owns a type II active pharmaceutical ingredient drug master file that is referenced, on or after the effective date in a generic drug submission by an initial letter of authorization. This one-time fee for each individual DMF is due no later than the date on which the first generic drug submission is submitted that references the associated DMF, or 30 days after the published notice (i.e. November 24, 2012), whichever is later.

Also on October 25, 2012, FDA published the 2013 rate for the backlog fee related to generic drug user fees. The backlog fee of $17,434 is effective on October 1, 2012. Each person that owns a pending ANDA on October 1, 2012 -- i.e., an ANDA submission that has not received tentative FDA prior approval to the effective date -- is subject to the backlog fee for each such application. The backlog fee is a means for FDA to generate enough resources to process its backlog of ANDAs. FDA currently has an approximate backup of over 2,800 ANDAs. The backlog fee is due no later than 30 days after the published notice (i.e. November 24, 2012).

• Print
• Comments
• Trackbacks
• Share Link

This post was written by Jennifer Pike.

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 consultation meetings on process issues related to the initiative. By way of background, under the Prescription Drug User Fee Act, FDA must meet standards related to enhanced patient representation in drug regulation decision-making. The patient-focused drug development initiative fulfills this requirement. Under this initiative, FDA will conduct public meetings to consider 20 different disease areas. The first of these meetings, at which FDA will provide an overview of the initiative, will be held on October 25, 2012. Attendees will be invited to comment on FDA’s preliminary list of nominated diseases for the initiative and the criteria used to develop the list. The registration deadline is October 18, 2012, and comments may be submitted by November 1, 2012.  In addition to public meetings to consider disease areas, FDA will hold meetings with patient stakeholders to discuss key process questions for patient-focused drug development. The deadline for stakeholders to notify FDA of their intention to participate is October 3, 2012, and the first meeting will be held on October 10, 2012.

• Print
• Comments
• Trackbacks
• Share Link

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 to require domestic and foreign device establishments to submit their registration and device listing information to FDA by electronic means rather than on paper forms, and also specified the timeframes when establishments must submit such information. In addition, the final rule facilitates FDA’s collection of additional registration information from foreign establishments as required by the Public Health Security and Bioterrorism Preparedness and Response Act of 2002 (Bioterrorism Act). The final rule also updates certain provisions in the regulations to improve the quality of registration and listing information available to FDA. The final rule is effective October 1, 2012.

• Print
• Comments
• Trackbacks
• Share Link

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 with biosimilar biological product and prescription drug development, for certain applications and supplements for approval of biosimilar biological products, on establishments where approved biosimilar biological product products are made, and on biosimilar biological products after approval. The FY 2013 rates for both biosimilar and prescription drug fees are as follows: initial and annual fees -- $195,880; reactivation fee -- $391,760; fee for a product application requiring clinical data -- $1,958,800; fee for a product application not requiring clinical data -- $979,400; fee for a product supplement requiring clinical data -- $979,400; product establishment fee -- $526,500; and product fee -- $98,380. These fees are effective on October 1, 2012, and will remain in effect through September 30, 2013. 

• Print
• Comments
• Trackbacks
• Share Link

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 paid before or at the time the application is submitted to FDA. The standard fee for a premarket application is $248,000 for FY 2013. More information about the FY 2013 fees can be found at the FDA web site.

• Print
• Comments
• Trackbacks
• Share Link

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 where the rule provides for alternative placement of the UDI or provides an exception for a particular device or type of device (e.g., devices sold over-the-counter and low risk devices). Each UDI would be required to be provided in a plain-text version and in a form that uses automatic identification and data capture (AIDC) technology. The UDI also would be required to be directly marked on the device itself for certain categories of devices for which the labeling requirement may not be sufficient (e.g., those that remain in use for an extended period of time and devices that are likely to become separated from their labeling). The proposed rule would require the submission of information concerning each device to a database that FDA intends to make public, to ensure that the UDI can be used to adequately identify the device through its distribution and use. Comments will be accepted on the proposed rule until November 7, 2012.

• Print
• Comments
• Trackbacks
• Share Link

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 for a research or marketing permit for other kinds of products regulated by FDA. The rule is effective May 30, 2012.

• Print
• Comments
• Trackbacks
• Share Link

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 flexibility needed for sterility testing of novel products that may be introduced to the market, enhancing sterility testing of currently approved products, and encouraging manufacturers to utilize scientific and technological advances in sterility test methods as they become available. 

• Print
• Comments
• Trackbacks
• Share Link

This post was written by Erin A. Janssen.

On February 6, 2012, the FDA adopted as a final rule, without change, the interim final rule from December 28, 2007 that permitted FDA Center Directors to grant exceptions or alternatives to certain regulatory labeling requirements applicable to human drugs, biological products, or medical devices that are or will be included in the Strategic National Stockpile. FDA took action via the announcement in the Federal Register to complete the rulemaking initiated with the interim final rule.
 

• Print
• Comments
• Trackbacks
• Share Link