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 Issues Draft Guidances for Prior Approval Supplements and Amendments / Easily Correctable Deficiencies Under GDUFA
The Generic Drug User Fee Amendments of 2012 (GDUFA) were signed into law on July 9, 2012, in an effort “to speed access to safe and effective generic drugs to the public and reduce costs to industry.” In July 2014, the U.S. Food and Drug Administration issued two draft Guidances for Industry: one relating to Prior Approval Supplements Under GDUFA and one relating to Amendments and Easily Correctable Deficiencies Under GDUFA.
Click here to read the full Alert written by Duane Morris partner Rick Ball and associate Carolyn Alenci.
Duane Morris Partner Frederick Ball to Moderate at the FDLI’s Conference, Celebrating the 30th Anniversary of the Hatch-Waxman Amendments: The Past, Present and Future of Generic Drugs
Duane Morris partner Frederick R. Ball will be serving as a moderator on a session titled “The Present Part 2: Generic Industry Challenges and Current Issues” at the Food and Drug Law Institute’s conference. The conference, Celebrating the 30th Anniversary of the Hatch-Waxman Amendments: The Past, Present and Future of Generic Drugs, will take place on September 18, 2014 in Washington, D.C. Mr. Ball’s session will begin at 1:45 p.m.
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FDA Issues Draft Guidance for Identification and Notification of Suspect Products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.