Tag Archives: fda

COVID-19 Treatment Approvals Accelerated by New FDA CTAP Program

On March 31, 2020, the U.S. Food & Drug Administration (FDA) introduced a specially designed “emergency program”—dubbed the Coronavirus Treatment Acceleration Program (CTAP)—to provide patients with faster access to new COVID-19 treatments. The CTAP allows FDA to “move new therapies to patients as quickly as possible, while at the same time finding out whether they are helpful or harmful.”

Given the rapidly increasing rate of COVID-19 confirmed cases and fatalities in the United States, efforts to streamline FDA processes may prove crucial to uncovering and delivering viable treatments.

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

FDA Virtual Town Hall for Laboratories and Manufacturers Developing Diagnostics Tests for COVID-19

FDA is hosting a virtual town hall April 1, 2020, at 12:15 p.m. Eastern for clinical laboratories and commercial manufacturers developing diagnostic tests for the COVID-19 virus. FDA intends to help answer technical questions about validation and development of tests and FDA’s recently issued Guidance from March 16, 2020 outlining FDA policy for development of diagnostic tests during the COVID-19 public health emergency.  FDA will host subsequent virtual town halls for clinical laboratories and commercial manufacturers each Wednesday of April at 12:15 p.m. Eastern. Registration not required. Details to join the call are available on the event page.

For additional information, please contact Dana J. AshFrederick R. BallPatrick C. Gallagher, Ph.D.Jonathan LourieVicki G. Norton, Ph.D., or Sandra G. Stoneman of Duane Morris’ LIfe Sciences Industry Group.

A Cannabidiol Catalyst? Recent Events Increase Pressure on FDA to Regulate CBD

By Justin M.L. Stern and Frederick R. Ball

For consumers, the widespread availability of products containing cannabidiol (CBD) is old news. But for those in the cannabis industry—and in particular, those monitoring applicable regulatory developments—the state of CBD remains largely in flux and continues to be marred by uncertainty.

Under the 2018 Farm Bill, the U.S. Food and Drug Administration (FDA) retained its regulatory authority over products derived from hemp, including CBD incorporated into products it traditionally regulates, such as food, dietary supplements, and cosmetics. Unfortunately for the industry, FDA has yet to propose or issue formal regulations concerning the manufacture, distribution, or sale of such products. At the same time, FDA has issued numerous warning letters to producers and retailers incorporating CBD into products operating in the complex gray area between state and federal law. Nevertheless, recent events occurring across all three federal branches of government may reflect an impetus for change in FDA’s approach to CBD products.

To read the full article, please visit the FDLI website.

FDA Guidance Aims to Accelerate Availability of COVID-19 Tests

On March 16, 2020, the U.S. Food & Drug Administration (FDA) issued new guidance aimed at accelerating the availability of COVID-19 diagnostic tests developed by laboratories and commercial manufacturers. The guidance, which took immediate effect upon release, contains recommendations for clinical laboratories and commercial manufacturers regarding development of diagnostic tests for COVID-19 during the current public health emergency.

As the guidance recognizes, there is currently an outbreak of a respiratory virus named SARS-CoV-2, which causes a disease named Coronavirus Disease 2019 (hence COVID-19). The guidance also acknowledges that COVID-19 poses a high potential public health threat “both globally and to the United States.” Effectively responding to the COVID-19 outbreak requires “rapid detection of cases and contacts, appropriate clinical management and infection control, and implementation of community mitigation efforts.”

To that end, the guidance describes a number of important policies concerning the circumstances under which certain entities may perform laboratory testing or distribute test kits on a more expedient timeline than would normally be permitted under FDA regulations and policies.

View the full Alert on the Duane Morris LLP website.

FDA’s Report on CBD Reaffirms Status Quo

Consumers want answers from FDA on how it plans to regulate the multibillion dollar market for CBD-related products—and they’re not alone. Under the Further Consolidated Appropriations Act, 2020 (P.L. 116-94), Congress directed FDA to provide a report concerning the agency’s progress in receiving and evaluating data to help inform a policy of enforcement discretion and a process by which FDA will evaluate cannabidiol (meeting the definition of hemp) in FDA-regulated products.

On March 5, 2020, FDA submitted the requested report, painting a more detailed view of its CBD-related activities than the public has seen to date. From a high level, FDA noted that it remains concerned about the potential safety risks posed by mislabeled or contaminated CBD-infused products. At the same time, FDA stated that it “is actively working to evaluate potential lawful pathways for the marketing of CBD.”

View the full Alert on the Duane Morris LLP website.

FDA Postpones Foreign Inspections Through April in Response to COVID-19

FDA announced on March 10, 2020, that the agency is postponing most foreign inspections through April, effective immediately. FDA will consider whether to conduct inspections outside the U.S. deemed mission-critical on a case-by-case basis.

Postponing foreign inspection will likely delay product application reviews that require facility inspections. FDA has committed to trying to mitigate any potential impact that the COVID-19 outbreak and suspension of foreign inspections may have regarding FDA action on product applications. The extent of that impact will likely depend on how soon foreign inspections can resume and the resources, including personnel, available to FDA once they resume.

View the full Alert on the Duane Morris LLP website.

FDA Revises Policies and Procedures for Prioritization of ANDAs in New MAPP

On January 30, 2020, the U.S. Food & Drug Administration (FDA) issued a new Manual of Policies & Procedures (MAPP) concerning how it will prioritize internal review of abbreviated new drug applications (ANDAs), amendments and supplements.

Whether a submission qualifies for priority designation can mean a substantial difference in approval time. As the FDA explains, it “may grant an ANDA submission either a shorter review goal date or an expedited review” if the submission satisfies a public health priority (or prioritization factor) described in the MAPP.

View the full Alert on the Duane Morris LLP website.

FDA Identifies Medical Devices and Systems Exempt From Premarket Notification Requirements

Before a medical device is brought to market, the FDA requires a premarket submission. For low risk devices, that submission is often via a 510(k), demonstrating that the device is at least as safe and effective as (substantially equivalent to) an already legally marketed device that is not subject to premarket approval.

As of December 30, 2019, certain Class I and Class II medical devices and systems that previously required a 510(k) submission are now, based on certain criteria detailed in the FDA’s rule, exempt from that requirement. The regulatory adjustment will mean that the dozens of medical devices and test systems identified will no longer have to comply with the premarket clearance, subject to certain conditions.

For example, among the impacted items are numerous drug detection systems, such as amphetamine test systems, barbiturate test systems, benzodiazepine test systems, codeine test systems, and methamphetamine test systems, all of which are exempt unless they are intended for any other use than employment, insurance, or federal drug testing programs. The new rule also affects other categories of devices and tests, such as unscented menstrual pads, assisted reproduction accessories and microtools, and breath-alcohol test systems.

Spate of FDA and FTC Warning Letters Sets Stage for Wave of False Advertising Consumer Class Action Lawsuits

Since the 2018 Farm Bill passed in December 2018, removing hemp from the Controlled Substances Act and thus legalizing it under federal law, consumer goods containing the hemp-derivative cannabidiol (CBD) have become exceptionally popular. With that growing popularity among consumers has come increased scrutiny by federal regulators whose mission is consumer safety and protection, such as the Food and Drug Administration and Federal Trade Commission, and now by the plaintiffs’ bar, which files consumer class actions based on advertising. As the recent spate of warning letters and consumer class actions demonstrate, hemp-derived CBD product manufacturers and others in the supply chain for those products have to be mindful of the claims they make to consumers about their products.

View the full Alert on the Duane Morris LLP website.

With a Flurry of Warning Letters and a Consumer Update, FDA Signals Commitment to CBD Enforcement Policy

On November 25, 2019, the U.S. Food & Drug Administration (FDA) announced that it had issued warning letters to 15 U.S. businesses engaged in the sale of products containing cannabidiol (CBD); that it had published a revised Consumer Update detailing safety concerns about CBD products; and that it “cannot conclude that CBD is generally recognized as safe (GRAS)” for use in human or animal food. These actions and statements by FDA cut against industrywide hopes that FDA might soon realign its enforcement policy in light of market realities.

View the full Alert on the Duane Morris LLP website.