Duane Morris – Page 8 – Duane Morris Life Sciences Law

June 18, 2020 by Duane Morris

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.

June 12, 2020 by Duane Morris

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.

June 2, 2020 by Duane Morris

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.

May 29, 2020 by Duane Morris

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.

May 27, 2020 by Duane Morris

U.S. Pharmacists and Pharmacies Authorized to Order and Administer COVID-19 Diagnostic Tests

In further clarification to pharmacists and pharmacies around the country, on May 19, 2020, the Department of Health and Human Services (HHS) issued an advisory opinion determining that pharmacies in the United States, regardless of state or local requirements, are authorized to order and administer COVID-19 diagnostic tests under the Public Readiness and Emergency Preparedness (PREP) Act.

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

April 24, 2020 by Duane Morris

HHS Clarifies Broad Scope of Immunity Protection Under the PREP Act

The Department of Health & Human Services (HHS) has provided an omnibus advisory opinion in response to various requests for clarification of the scope of tort immunity provided by the declaration under the Public Readiness and Emergency Preparedness Act (PREP Act). The PREP Act declaration provides immunity from tort liability for various persons, products and activities in response to COVID-19, as explained in our March 17, 2020, Alert. The Coronavirus Aid, Relief and Economic Security Act (CARES Act) subsequently expanded these protections.

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

April 22, 2020 by Duane Morris

U.S. Food & Drug Administration Takes Steps to Allow Availability of PPE

Over the past week, the U.S. Food & Drug Administration (FDA) has taken a number of steps to enable manufacturers and distributors of face masks to more efficiently make their products available to the marketplace. FDA has accomplished this by establishing criteria that would allow manufacturers to bypass normally required (and often time-consuming) regulatory review.

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

April 16, 2020 by Duane Morris

PPE and Other Medical Devices from 3D Printing

During the COVID-19 pandemic, the demand for personal protective equipment (PPE) has significantly outpaced the capabilities of the traditional supply chain. Gowns, gloves, facemasks, and face shields are valued commodities that even many healthcare providers cannot secure in this environment. While traditional supply and manufacturing chains struggle to keep up with production, industry leaders have turned to 3D printing, or additive manufacturing technology, to address this dire need. Unlike traditional manufacturing methods, companies with already established additive manufacturing technologies can more readily and efficiently adapt their productions to manufacture such PPE. 3D printing manufacturers may already have the powder or fabric necessary to manufacture PPE. They also have versatile printers. These companies simply need software and product design specifications, which allows them to begin production much more quickly than companies relying on traditional manufacturing methods that require additional raw materials and even machines and equipment.

For example, Superfeet, a shoe insert manufacturer, which typically uses 3D printing for manufacturing its products, was contacted about its ability to assist with a shortage of powered air purifying respirators (PAPR) hoods to hospitals in Washington state. The company had printers and fabric already. In just a few short days, Superfeet was making PPE.

To read the full text of the article by Duane Morris , visit the MD+DI website.

April 13, 2020 by Duane Morris

Immunity Protections Expanded Under CARES Act for Covered Countermeasures and Healthcare Volunteers

As discussed in our March 18 Alert, the Secretary of Health and Human Services has issued a declaration authorizing drugs, devices and biologics used to treat or mitigate COVID-19 as covered countermeasures under the Public Readiness and Emergency Preparedness (PREP) Act. Following Secretary Azar’s declaration of a public health emergency, covered persons may obtain immunity under federal law for all claims arising from manufacturing, distributing or administering covered countermeasures, subject to the conditions laid out at 42 U.S.C. § 247d-6d, the declaration and other applicable regulations.

Subsequent to our previous Alert, President Trump signed into law the Coronavirus Aid, Relief and Economic Security Act (CARES Act), which expanded the covered countermeasure protections offered by the PREP Act.

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

April 13, 2020 by Duane Morris

CARES Act Package Ushers in Changes to OTC Drug Review Process

Most of the hundreds of pages comprising the CARES Act, signed into law on March 27, 2020, concern measures for directly counteracting COVID-19 and assisting those dealing with economic consequences of the pandemic. Yet tucked away in Subtitle F of the legislation are a number of provisions—now law—which streamline FDA’s over-the-counter (OTC) drug review process. These changes are likely to lower the regulatory burden of getting a product through the OTC drug review process and provide incentives of market exclusivity for companies who do.

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