Tag Archives: fda

Expanding Access to Experimental Drugs

Drug and biologic developers have faced increasing pressure from patients and their advocates to make investigational drugs available for compassionate use prior to approval by the Food and Drug Administration (FDA). Over the past year social media campaigns have spotlighted patients seeking early access to potentially life-saving treatments, drawing attention to the growing debate between patient advocates promoting wider access to investigational drugs, and those urging more cautious approaches. Propelled by the plight of critically ill patients desperately seeking new treatments, several states have passed laws giving patients the “Right to Try” investigational drugs or biologics. FDA has also taken steps to make its “Expanded Access” process more user-friendly, and the Agency continues to solicit input from patient groups on risk-benefit analysis and available treatments as part of its Patient-Focused Drug Development Initiative.

Companies may want to monitor regulatory and legislative developments relating to early access to investigational treatments, and to adopt formal compassionate use policies.

Continue reading Expanding Access to Experimental Drugs

FDA’s Final Guidance on the Circumstances That Constitute Interference with a Drug Inspection

The U.S. Food and Drug Administration (FDA) recently published its final Guidance for Industry detailing circumstances that would constitute interference with a drug inspection under the Food and Drug Administration Safety and Innovation Act (FDASIA), signed into law on July 9, 2012.

Prior to the passage of the FDASIA, sections 301(e) and 301(f) of the Food, Drug, and Cosmetic Act (FD&C Act) prohibited drug facilities from denying FDA: (1) entry or the opportunity for inspection or; (2) refusing access to or the opportunity to copy specific records. Section 707 of the FDASIA extends this prohibition, through section 501(j) of the FD&C Act, by deeming a drug adulterated if ” … it has been manufactured, processed, packed, or held in any factory, warehouse, or establishment and the owner, operator, or agent of such factory, warehouse, or establishment delays, denies, or limits an inspection, or refuses to permit entry or inspection.” This provision extends to “any factory, warehouse, or establishment in which … drugs … are manufactured, processed, packed, or held, for introduction into interstate commerce or after such introduction, or to enter any vehicle being used to transport or hold such … drugs … in interstate commerce.” FDASIA also adds section 704(a)(4) to the FD&C Act, allowing FDA to “request, in advance of or in lieu of an inspection, within a reasonable timeframe, within reasonable limits, and in a reasonable manner, records or information that FDA may inspect under section 704(a).”

To read the full text of this Alert, please visit the Duane Morris website.

FDA Issues Guidance on Registration, Fees and Reporting Requirements for Drug Compounding Outsourcing Facilities

On November 21, 2014, the U.S. Food and Drug Administration (FDA) announced the release of three new guidance documents related to drug compounding outsourcing facilities. These documents include:

FDA Report on Standardizing and Evaluating Risk Evaluation and Mitigation Strategies (REMS)

The U.S. Food and Drug Administration (FDA) recently published a report titled “Standardizing and Evaluating Risk Evaluation and Mitigation Strategies (REMS),” which summarizes stakeholder engagements completed in fiscal year 2013 and fulfills FDA’s Prescription Drug User Fee Act (PDUFA) commitment to issue a report of its findings regarding REMS standardization.

FDA Gives Guidance on Compounding for Human Use

In July 2014, the U.S. Food and Drug Administration (FDA) released five documents containing policies and proposals that affect both traditional compounding pharmacies and outsourcing facilities that compound drugs for human use. These FDA guidance documents and proposed rule are the latest FDA action to implement its new authority under the CQA to regulate the compounding of drugs for human use. FDA’s current thinking, its proposed regulation and Final Guidance are key guideposts for entities compounding for human use under either Section 503A, Section 503B, or both.

Click here to read the full Alert.

FDA Issues Draft Guidance for Identification and Notification of Suspect Products

As discussed in our April 11, 2014 Alert, the Drug Supply Chain Security Act (DSCSA) was enacted “to build an electronic, interoperable system to identify and trace certain prescription drugs as they are distributed within the United States.” Recently, the U.S. Food and Drug Administration (FDA) has issued a draft Guidance for Industry for implementing the DSCSA with respect to identification of suspect products and notification thereof.

Starting January 1, 2015, trading partners and manufacturers are required to “notify FDA and immediate trading partners (that they have reason to believe may have received [or possess] the illegitimate product) not later than 24 hours after making the determination.”

Click here to read the full Alert, written by Duane Morris partner Rick Ball and associate Carolyn Alenci.

FDA Releases Guidance for Industry on ANDAs: Stability Testing of Drug Substances and Products, Questions and Answers

The U.S. Food and Drug Administration (FDA) recently published a new Guidance for Industry, titled ANDAs: Stability Testing of Drug Substances and Products, Questions and Answers, which provides answers to questions from public comments received on the draft Guidance for Industry on ANDAs: Stability Testing of Drug Substances and Products (“FDA stability guidance”) that was published in the Federal Register on September 25, 2012. It also incorporates comments received on the same draft, which were previously published in the Federal Register on August 27, 2013.

Click here to read this Alert, written by Duane Morris Partner Rick Ball and associate Emily Winfield.