Food & Drug Administration Regulations

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Last February, the Food and Drug Administration (FDA) asked for public feedback on a proposed research study related to prescription drug television advertisements. In a notice published in the Federal Register on January 13, 2015, FDA announced its intention to continue to move forward with the proposed study. Specifically, the notice announced that…

This post was written by Kevin M. Madagan.

Time to pop the bubbly a little early! FDA announced today that the Drug Supply Chain Security Act (DSCSA) deadline of January 1, 2015 for product tracing (i.e., the new federal pedigree standards) will not be enforced until May 1, 2015. This means manufacturers, wholesale distributors, and repackagers…

The FDA has scheduled a public workshop on the “Framework for Regulatory Oversight of Laboratory Developed Tests” on January 8 – 9, 2015. The purpose of the workshop is to discuss FDA’s proposal for a risk-based framework for addressing the regulatory oversight of “laboratory developed tests,” a subset of vitro diagnostic devices intended…

Earlier this summer, the Food and Drug Administration (FDA) issued a draft 42-page “Informed Consent Information Sheet” that provides guidance for institutional review boards (IRBs), clinical investigators, and clinical trial sponsors on complying with the Agency’s informed consent regulations. Once finalized, the draft guidance will supersede FDA’s previous Information Sheet on this topic, “A Guide to Informed Consent,” which was last updated over 15 years ago, in 1998.  The guidance, which is a compilation of FDA’s regulations and past guidances on informed consent, also reflects the Agency’s coordinated efforts with the Department of Health and Human Services (HHS) to facilitate consistency across informed consent requirements and policies among federal government agencies.

Broadly, the new guidance indicates FDA policy shifting towards enhanced informed consent processes. More narrowly, the draft guidance explains the various and often caveated elements of informed consent (including providing patients with a description of the trial, its risks, benefits, alternative treatments, confidentiality and compensation in the event of injury), depicts the detailed responsibilities of IRBs, clinical investigators and sponsors of clinical trials (including compliance with the process, elements and documentation of informed consent), and provides examples of recommended language to assist industry parties in complying with FDA’s informed consent regulations. FDA accomplishes this task by clarifying some aspects of existing guidance and creating additional guidance in new areas.

The following provides an overview of some of the draft guidance’s notable new and revised provisions.Continue Reading FDA Seeks Comments to Updated Guidance on Informed Consent in Clinical Trials

In a notice published in the Federal Register on May 7, 2014, the U.S. Food and Drug Administration (“FDA”) announced its intent to incentivize manufacturers to voluntarily update their prescription drug and biologics labels by using a government contractor.

FDA’s announcement stems from a January 2006 final rule in which FDA established revised content and…

This post was written by Jillian W. Riley.

Earlier this week, FDA’s Center for Devices and Radiological Health (CDRH) published two separate draft guidance documents to advance the dual goals of FDA and industry to provide pathways for medical devices to reach the market quickly while ensuring the safety and efficacy of the product.

The…

On March 25, 2014, the Food and Drug Administration (FDA) published a proposal to amend its regulations governing the classification and reclassification of medical devices. In addition to conforming the regulations to recent changes made by the 2012 Food and Drug Administration Safety and Innovation Act (FDASIA), the proposed rule makes changes unrelated to…

As mentioned on our Life Sciences Legal Update blog, the Food and Drug Administration (FDA) announced today it has proposed significant updates to the Nutrition Facts label for foods intended to expand and highlight the information consumers need to make well-informed food choices.  FDA also is proposing changes to how serving sizes themselves are calculated.

This post was also written by Jillian W. Riley.

The Food and Drug Administration (FDA) has just announced that it will hold a public hearing March 25 and 26, 2014 to obtain input on the Agency’s current process for reviewing over-the-counter (OTC) drugs. This is a significant advancement in FDA’s long-standing plan to overhaul the OTC drug system. According to the announcement, the Agency’s OTC drug review “needs a critical examination at this juncture to examine whether and how to modernize its processes and regulatory framework.”

Teeing up the importance of the public hearing, Dr. Janet Woodcock, the Director of FDA’s Center for Drug Evaluation and Research (CDER), informed the Wall Street Journal that the Agency was “looking for creative ideas about how to improve the process.”1 According to Dr. Woodcock, “The current system isn’t working well for the public or for us.”  Additional details are available after the jump.Continue Reading FDA to Overhaul an OTC System That “Isn’t Working”

In a notice published in the Federal Register on February 18, 2014, the Food and Drug Administration (FDA) asked for feedback on a proposed research study related to prescription drug television advertisements. The study, Disclosure Regarding Additional Risks in Direct-to-Consumer (DTC) Prescription Drug Television (TV) Advertisements (Ads), would investigate the impact of limiting the…

As reported on our Life Sciences Legal Update blog, the FDA has issued draft guidance addressing the unique challenges of drug promotion in the age of social media. Specifically, the draft guidance addresses how to submit interactive promotional media for postmarket review.  Comments on the document, “Draft Guidance for Industry on Fulfilling Regulatory…

In October 2011, CMS and the FDA formally launched a voluntary parallel review pilot program for sponsors of medical devices. At the time, the agencies stated that they intended to run the pilot program for two years, with the possibility of an extension. In a December 18, 2013 notice, the FDA and CMS announced that…

The Food and Drug Administration (FDA) has announced the availability of a final guidance document which describes the qualification process for drug development tools (DDTs) intended for use, over time, in multiple drug development programs. DDTs are methods, materials, or measures that aid drug development. Examples of DDTs include biomarkers and patient reported outcome instruments.…

On July 15, 2013, the Food and Drug Administration (FDA) published in the Federal Register a proposed rule that would amend 21 CFR Part 1 to implement FDA’s detention authority with respect to drugs intended for human or animal use. FDA’s detention authority is authorized by amendments made to the Food, Drug, and Cosmetic Act…

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…

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.…