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November 9, 2018 by Duane Morris

CDER’s New MAPP on Risk-Based Site Selection Model for Routine Inspections

The Food and Drug Administration’s Center for Drug Evaluation and Research (CDER) published a new Manual of Policies and Procedures (MAPP) for the Site Selection Model (SSM) used to prioritize manufacturing sites for routine current good manufacturing practice inspections. As in the past, FDA will use a risk-based approach to inspections of both domestic and foreign drug establishments in order to promote parity in inspectional coverage (i.e., equal frequency for sites with equivalent risk regardless of geography or product type) and effective and efficient use of FDA’s resources.

We invite you to read the full text of this Duane Morris Alert on the firm website.

November 5, 2018 by Duane Morris

Five Good Habits of University Researchers Launching Spinouts

By Sandra G. Stoneman and Matthew C. Mousley

Photo of attorney Sandra Stoneman — Sandra G. Stoneman

Photo of attorney Matthew Mousley — Matthew C. Mousley

If you are a university researcher interested in launching a startup based on an invention developed in your lab, below is a list of some key guidelines to keep in mind as you start your company: Continue reading “Five Good Habits of University Researchers Launching Spinouts”

October 25, 2018 by Duane Morris

SUPPORT Act Expands Sunshine Act Disclosure Requirements, Covered Recipients

On October 24, 2018, President Donald Trump signed the Substance Use-Disorder Prevention that Promotes Opioid Recovery and Treatment for Patients and Communities Act (SUPPORT Act), a combination of a number of previously passed House and Senate bills related to addressing the opioid crisis. One of the provisions of this lengthy bipartisan package of bills includes an expansion of the disclosure requirements initially imposed by the Physician Payments Sunshine Act.

Read the full text of this Alert on the Duane Morris LLP website.

October 22, 2018 by Duane Morris

FDA Rolls Out Pilot of New Quality in 510(k) “Quik” Review Program

The 510(k) process provides a review procedure for marketing clearance of devices that are “substantially equivalent” to other approved devices or to a standard recognized by the Food and Drug Administration (FDA).

On September 6, 2018, the FDA launched an alternate to the Traditional 510(k) for submitting a Premarket Notification (510(k)). The FDA calls the alternative the Quality in 510(k) “Quik” Review Program Pilot. Under the program, the FDA’s goal is “to make a final decision within 60 days.”

Read the full text of this Alert on the Duane Morris LLP website.

October 4, 2018 by Duane Morris

FDA Estimates for Formal Meetings Show Continued Growth of Biosimilars in the United States

Among the key aspects in the development of a biosimilar product for the U.S. market is taking advantage of formal meetings with the U.S. Food and Drug Administration to gain insight on moving a clinical development program for a proposed biosimilar product forward. Tracking meeting requests is also one way to measure the prospects for growth and health of the U.S. biosimilars industry. By that measure, the prospects for the U.S. biosimilars industry look bullish. This year, FDA revised its estimate for meeting requests upward by six respondents to Center for Drug Evaluation and Research (CDER) meeting requests, reflecting the industry’s confidence in the growth of biosimilar market share in the United States.

FDA’s upward projection is consistent with independent estimates of potential biosimilar cost savings in the United States. In 2014, Rand Corporation estimated biosimilar cost savings over the next decade to be $44 billion. By 2017, Rand Corporation estimated biosimilar cost savings over the next decade to be $54 billion. The increase in estimated cost savings is premised on biosimilars gaining in market share of biologics prescriptions. These signs are all pointing toward increased growth of the U.S. biosimilars industry.

Read the full text of this client Alert, including lists of what to have prepared for meeting requests and the actual meetings, on the Duane Morris LLP website.

December 24, 2014 by Duane Morris

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.

December 9, 2014May 22, 2017 by Duane Morris

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:

Final Guidance on registration of human drug compounding outsourcing facilities
Final Guidance on registration fees for such outsourcing facilities
Revised Draft Guidance on electronic drug product reporting requirements for compounding outsourcing facilities

As detailed in an earlier Duane Morris Alert, the 2013 Drug Quality and Securities Act (DQSA) added Section 503B to the Food, Drug, and Cosmetic Act (FDCA), which established federal oversight for human drug compounding outsourcing pharmacies (outsourcing facilities).

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

December 3, 2014 by Duane Morris

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.

August 4, 2014September 10, 2014 by Duane Morris

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.

July 31, 2014September 10, 2014 by Duane Morris

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.

Continue reading “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”