All posts by DuaneMorris3

FDA’s New MAPP Shows the Route to Changing Ownership of Generic Drug Applications

The U.S. Food & Drug Administration (FDA) recently issued a new Manual of Policies and Procedures (MAPP), in which it explains the Office of Generic Drugs’ (OGD) policy on facilitating changes to generic drug applications and updating the Orange Book to reflect those changes.

MAPP 5242.1 makes clear that the policies, processes and procedures for changing ownership of an application differ based on whether the change is effected by a simple transfer of ownership or whether it results from a corporate merger or acquisition.

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

New Guidance Reveals FDA’s Thinking on Imposition of Civil Monetary Penalties for Violations of Clinical Trial Reporting Requirements

In August 2020, the U.S. Food and Drug Administration issued guidance on the imposition of civil monetary penalties for violations of clinical trial reporting requirements. The new guidance is welcome insight for members of the pharmaceutical, biologics and medical device industries, particularly in light of the race to develop—and convince FDA of the safety and effectiveness of—COVID-19 vaccines, therapeutics and diagnostic tests.

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

FDA Clarifies Policy on Scope of Review of Multiple-Function Device Products

On July 29, 2020, the U.S. Food & Drug Administration (FDA) issued guidance containing its current thinking, policies and recommendations relating to the manufacturing and marketing of “multiple function” device products—products comprised of at least one FDA-regulated “device” function and at least one “other function”—a function that either does not meet the definition of a “device” under the Federal Food, Drug & Cosmetic Act; that is not subject to premarket approval; or for which the FDA has expressed an intention not to enforce regulatory compliance.

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

Discussion of Nondrug CBD Products Omitted on New FDA Draft Guidance on Cannabis-Related Clinical Research

On July 21, 2020, the U.S. Food & Drug Administration (FDA) issued draft guidance outlining the agency’s current thinking on the development of drugs containing cannabis or cannabis-derived compounds. The new guidance is disappointing to many in the cannabis industry because it does not provide insight into the FDA’s views on the marketing of nondrug, hemp-derived CBD products.

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

FDA Issues Guidance on Procedures for Device Establishment Inspections

On June 29, 2020, the U.S. Food & Drug Administration (FDA) issued guidance on how it will implement certain inspection procedures with respect to device establishments—facilities where medical devices are manufactured. The FDA’s guidance contains recommendations about (1) preannouncement notice (and communications prior to an establishment inspection); (2) inspection durations and timeframes; and (3) communications between the establishment’s representative and FDA’s inspector(s) during the inspection process.

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

Playing Your Cards Right: Arguments Against Obviousness Can Be Detrimental for Satisfying the Written Description Requirement

U.S. patent law establishes requirements that inventors and applicants must satisfy to obtain a patent, which include utility, recitation of patent eligible subject matter, novelty, nonobviousness, an adequate written description, enablement and the best mode of practicing the invention. Biogen International GmbH v. Mylan Pharmaceuticals, Inc. presents an example of tensions between the nonobviousness and written description requirements.

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

Temporary Policy on Distribution of Drug Samples During COVID-19 Issued by FDA

In response to the ongoing COVID-19 public health emergency, the United States Food and Drug Administration (FDA) issued a temporary policy related to the distribution of drug samples. Recognizing the unique challenges currently facing manufacturers that distribute drug samples as part of marketing efforts and the healthcare providers requesting those samples for patients, the FDA is temporarily easing certain requirements of the Prescription Drug Marketing Act.

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

FDA Expectations for Inspections of CDER- or CDRH-Led Combination Product Manufacturers Detailed in New FDA Compliance Program

On June 4, 2020, the U.S. Food & Drug Administration implemented a compliance program, which explains how CGMP requirements are to be applied to combination products, the subject of a final guidance issued in January 2017. In particular, the new program document focuses on providing a framework for conducting inspections of manufacturers of single-entity and co-packaged finished combination products—led by either the Center for Drug Evaluation and Research or the Center for Devices and Radiological Health—that include both (i) drug and device; or (ii) biological product and device constituent parts. In addition, because the underlying 2017 Guidance was issued by OPD, CBER, CDER and CDRH collectively, the same principals would like apply to inspections  in which CBER is the lead center.

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

Two New Guidances from FDA Related to Drugs and Biological Products Proposed for Use Against COVID-19

On May 11, 2020, the FDA issued two new guidances for industry and investigators of drugs and biological products proposed for use against COVID-19. These two guidances, “COVID-19 Public Health Emergency: General Considerations for Pre-IND Meetings Requests for COVID-19 Related Drugs and Biological Products” and “COVID-19: Developing Drugs and Biological Products for Treatment of Prevention,” provide insight into the expectations of the FDA regarding new treatment drug development programs in the fight against COVID-19.

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

COVID-19 Antibody Testing Guidance Provided by CDC

On May 26, 2020, the Centers for Disease Control and Prevention issued interim guidelines for COVID-19 antibody testing in clinical and public health laboratories. The guidelines contain recommendations for clinical and public health laboratories regarding: choice of test and testing strategy; individuals who test positive for COVID-19 antibodies; and additional considerations on the use of antibody tests.

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