Food & Drug Administration Developments

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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…

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…

On January 17, 2012 the FDA announced an opportunity for public comment on its Healthcare Professional Survey of Prescription Drug Promotion. This survey is designed to explore the opinions and perceptions of physicians, nurse practitioners, and physician assistants with regard to the promotion of prescription drugs to consumers and healthcare providers. FDA is inviting…

In light of public health concerns related to drug shortages, the Food and Drug Administration (FDA) has issued an interim final rule with comment period to clarify and modify regulations requiring sole manufacturers of certain critical drugs to report to the FDA any interruption in manufacturing that could lead to a potential disruption in supply …

On December 7, 2011, the Food & Drug Administration (FDA) published a notice discussing its proposed recommendations for implementing the ACA’s user fee program for biosimilar biological products for FYs 2013 through 2017. The notice summarizes the four proposed types of fees (Biosimilar Product Development Fees, Marketing Application Fees, Establishment Fees and Product Fees), along with …

This post was written by Erin Janssen.

The Food and Drug Administration (FDA) has published a notice announcing that it will conduct a review of its 2004 ‘‘Bar Code Final Rule,” which requires certain human drug products and biological products to have a bar code. The rule was intended to help reduce the…

The Food and Drug Administration (FDA) published a proposed rule on October 19, 2011 that would amend the 1992 Orphan Drug Regulations that implement the Orphan Drug Act. The amendments proposed are “intended to assist sponsors who are seeking and who have obtained orphan drug designation of their drugs, as well as FDA in…

On October 7, 2011, the Centers for Medicare & Medicaid Services and the Food and Drug Administration announced they are soliciting nominations from sponsors of medical devices to participate in a parallel review pilot program. The Agencies officially published a Federal Register notice announcing the program October 11, 2011 (the “Notice”), with an effective date…

This post was written by Erin Janssen.

On September 1, 2011, HHS published a notice extending the comment period for the advance notice of proposed rulemaking (ANPRM) on how current regulations for protecting human subjects might be modernized and revised to be more effective. That ANPRM, entitled “Human Subjects Research Protections: Enhancing Protections for…

This post was written by Erin Janssen.

On July 20, 2011, the FDA issued both a final rule and a guidance document regarding the classification of Focused Ultrasound Stimulators for Aesthetic Use as Class II Special Control devices.  The final rule indicated that the special control(s) that will apply to the device is the guidance…

This post was written by Erin A. Janssen and Areta L. Kupchyk.

On July 14, 2011, the FDA issued draft guidance entitled “In Vitro Companion Diagnostic Devices.” The guidance is intended to assist sponsors planning to develop a therapeutic product that depends on the use of an in vitro companion diagnostic device for its safe…

This post was written by Erin A. Janssen and Areta L. Kupchyk.

On July 14, 2011, the Food and Drug Administration (FDA) published a proposed rule to remove a section of the Prescription Drug Marketing Act (PDMA) regulations to permit wholesale distributors to document the chain of custody (also known as the “pedigree”) of prescription…

This post was written by Erin A. Janssen.

On June 21, 2011, the Food and Drug Administration (FDA) published a proposed rule that would amend current sterility test requirements for biological products to provide manufacturers with greater flexibility and to encourage use of the most appropriate and state-of-the-art test methods for assuring the safety of…

FDA has released for public comment a draft guidance document entitled “Financial Disclosures by Clinical Investigators.”   The guidance, which will supersede March 2001 guidance on this issue, seeks to respond to a January 2009 HHS Office of the Inspector General (OIG) report that concluded that clinical investigators may not be disclosing all financial interests ().…

The Food and Drug Administration (FDA) published a notice on May 10, 2011 seeking comments on its upcoming user fee program for biosimilar and interchangeable biological product (351(k)) applications. The user fee program was mandated by the Biologics Price Competition and Innovation Act of 2009, which was enacted as part of the Affordable Care …

This post was written by Paul Sheives.

Under Executive Order 13563, ‘‘Improving Regulation and Regulatory Review,’’ FDA is reviewing the effectiveness of the Agency’s regulations in light of public health needs and advances in innovation. To this end, FDA requests public comment and supporting data on which of its existing rules are outmoded, ineffective,…

This post was written by Paul Sheives.

The FDA has released for public comment a draft guidance document entitled “Processing/Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling.”  The recommendations in this guidance are intended to improve the safety and effectiveness of devices with processing or reprocessing labeling. The guidance…

This post was written by Paul Sheives.

FDA has announced the reestablishment of its Medical Imaging Drugs Advisory Committee (MIDAC).  The MIDAC reviews and evaluates data concerning the safety and effectiveness of marketed and investigational human drug products for use in diagnostic and therapeutic procedures using radioactive pharmaceuticals and contrast media used in…

This post was written by Paul Sheives. The Food and Drug Administration (FDA) has published a final rule entitled “Revision of the Requirements for Constituent Materials.” The rule allows FDA to approve exceptions or alternatives to the regulation for constituent materials in biologics (i.e., ingredients, preservatives, diluents, adjuvants, extraneous protein, and antibiotics…

This post was also written by Areta Kupchyk.

The FDA has published a final rule reclassifying Medical Device Data Systems (MDDS) as Class I medical devices exempt from 510(k) premarket notification requirements. FDA defines MDDS as medical devices that are intended to transfer, store, convert from one format to another according to preset specifications,…