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Operation Warp Speed and Vaccine Distribution Policies

Since March 2020, and in some cases before, the U.S. government, Congress and external entities have worked to design plans to reduce the impact of COVID-19 and ultimately prepare for the development and distribution of a...more

Healthcare Policy Update: Election Edition

A presidential race called by media outlets for former Vice President Joe Biden, coupled with a diminished Democratic majority in the U.S. House of Representatives and a narrowly divided Senate, translates into a federal...more

Hemp Industry Brings Case Against DEA to Clarify DEA's Hemp Rule

A hemp trade association and a hemp company have filed a petition in the U.S. Court of Appeals for the District of Columbia Circuit challenging the U.S. Drug Enforcement Administration's (DEA) Interim Final Rule (IFR). The...more

FDA Establishes a New Digital Health Center of Excellence

The U.S. Food and Drug Administration (FDA) has officially launched the Digital Health Center of Excellence within the Center for Devices and Radiological Health (CDRH) to expand the agency's activities in furtherance of its...more

USDA Seeks Additional Comments on a Dozen Outstanding Issues Related to Hemp Interim Final Rule

The U.S. Department of Agriculture (USDA) has officially requested additional comments on its Hemp Interim Final Rule (IFR). USDA's request, made on Sept. 8, 2020, follows ongoing industry feedback concerning a list of IFR...more

FinCEN Warns of Scams Relating to PPE and Other Medical Goods During COVID-19 Pandemic

In struggling to address the evolving COVID-19 pandemic, the United States and many other countries continue to face major shortages of Personal Protective Equipment (PPE), such as N95 masks, gowns and other vital materials...more

PREP Act: Liability Protection Is Available During COVID-19 Pandemic

Issues relating to liability for pharmaceutical, personal protective equipment (PPE) and diagnostic test businesses as well as for physicians and healthcare personnel in the coronavirus (COVID-19) context remains a salient...more

FDA Updates Policy for Antibody Tests for COVID-19: New Requirements for Manufacturers

In response to the COVID-19 pandemic and the need for more diagnostic testing, the U.S. Food and Drug Administration (FDA) has developed several pathways for manufacturers and developers of COVID-19 diagnostic tests to...more

Legal Insights on the Import of PPE and Other Medical Supplies Vital to Fighting COVID-19

The COVID-19 crisis has revealed the extent to which the United States and other countries are dependent upon a well-functioning global supply chain of critical medical supplies, including ventilators and Personal Protective...more

PPE Shortages: FDA and Chinese Government Issue New Policies for Masks, Gowns and Gloves

The widely reported shortages of Personal Protective Equipment (PPE), including masks and gowns, across the United States have led to the importation, distribution and use of PPE manufactured overseas. In particular, many...more

FDA's COVID-19 Guidance and Policy Update: March 23, 2020

The U.S. Food and Drug Administration (FDA) has issued several final guidance documents to assist manufacturers developing medical products in response to the coronavirus (COVID-19) pandemic. While some are published as...more

FDA Issues Guidance for Diagnostic Testing Applicable to Coronavirus Disease

The U.S. Food and Drug Administration (FDA) has issued a new guidance for novel coronavirus (COVID-19) molecular diagnostics tests developed and used in certain laboratories. The guidance, issued on Feb. 29, 2020, is designed...more

President Trump's Budget Seeks FDA Resources for CBD Enforcement | Insights

In the midst of expanded development and marketing of products containing cannabis and cannabis-derived compounds, President Donald Trump's FY 2021 proposed budget includes an additional $5 million for the U.S. Food and Drug...more

FDA Issues New Warnings and Raises Questions About Use of CBD

On November 25, 2019, the U.S. Food and Drug Administration (FDA) announced that it issued warning letters to several companies for illegally selling products containing cannabidiol (CBD). The FDA also published a revised...more

USDA Releases Interim Final Rule for Industrial Hemp Production, Requests Comments

The U.S. Department of Agriculture (USDA) has issued an Interim Final Rule (IFR) for the establishment of a domestic hemp production program. By publishing the rule in the form of an IFR, USDA is able to issue guidance before...more

FDA Publishes Consumer Update on Cannabis Products, Including CBD

On June 14, 2019, the FDA published a Consumer Update entitled "What You Need to Know (And What We're Working to Find Out) About Products Containing Cannabis or Cannabis-derived Compounds, Including CBD." In the Update,...more

FDA Considering Changes to Regulation of CBD Products - Agency Holds Public Hearing on Cannabis to Gather Input from Stakeholders,...

• With the dramatic expansion of CBD products in the market, the U.S. Food and Drug Administration (FDA) is reviewing whether its current regulatory framework is appropriate, and if not, what modifications are needed. • The...more

FDA Issues Statement on Cannabis Regulation and Announces Public Hearing

On April 2, 2019, FDA outlined new steps to advance review of potential regulatory pathways for cannabis-containing and cannabis-derived products. In a statement issued by Commissioner Scott Gottlieb, released in conjunction...more

FDA Open to “Alternative Approaches” to Regulating CBD

FDA has announced plans to seek congressional and stakeholder input on "possible alternative approaches" to regulating cannabis and cannabis-derived products. The announcement came as Commissioner Scott Gottlieb spoke on the...more

Government Re-Opens: Impact on FDA

The federal government shutdown ended Friday, Jan. 25, 2019, with the enactment of a Continuing Resolution to fund government agencies at approximately FY19 levels through Feb. 15. That means federal employees are headed back...more

FDA Announces New Policies to Advance Cell and Gene Therapies

On Jan. 15, 2019, Food and Drug Administration (FDA) Commissioner Scott Gottlieb and Center for Biologics Evaluation and Research (CBER) Director Peter Marks issued a statement proposing policies to support cell and gene...more

The Government Shutdown and Its Effects on the FDA

Note - On January 25, President Trump announced that the White House and congressional leaders in the House and Senate have reached an agreement to fund the government on a short-term continuing resolution (CR) through Feb....more

Hemp is Now Legal, But What Does That Actually Mean?

With the enactment of the Agriculture Improvement Act of 2018 (Farm Bill) on Dec. 20, 2018, hemp and cannabis derivatives with extremely low concentrations of Tetrahydrocannabinol (THC)—less than 0.3 percent on a dry weight...more

FDA Issues Warning Letter Regarding Unapproved Stem Cell Products

The U.S. Food and Drug Administration (FDA) issued a statement on Dec. 20, 2018, once again putting stem cell companies on notice about its intention to crack down on the marketing of unapproved stem cell products, and...more

FDA Commissioner Speaks Out on Compliance and Enforcement

On Dec. 12, 2018, U.S. Food and Drug Administration (FDA) Commissioner Scott Gottlieb announced tougher compliance and enforcement policies for drug manufacturers, dietary supplement manufacturers, stem cell clinics and...more

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