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We are now in the second year of the ten-year implementation of the DSCSA.

The Internet revolutionized how we obtain information, and social media has revolutionized how we share it. Yet the current regulatory landscape created by the Food and Drug Administration (FDA) for medical product manufacturers is comprised of rules designed for old media, wherein a medical product manufacturer’s on-line speech and active participation in the dissemination of truthful product information creates an enormous risk of civil and criminal prosecution.

On May 7, 2015, the Food and Drug Administration (FDA) published its draft Guidance for Industry Questions and Answers Regarding Mandatory Food Recalls and opened its docket seeking comments.

A New FDA Draft Guidance Adds Significant Compliance Obligations and Potential for Adulteration and Manufacturing Defect Claims.

In 2011, the US Supreme Court decided Sorrell v US, holding that "[s]peech in aid of pharmaceutical marketing . . . is a form of expression protected by the Free Speech Clause of the First Amendment."

If you think this case is about Shostakovich or Stravinsky, think again. At issue in Golan v Holder No. 10-545, 131 S.Ct. 1600, writ of certiorari granted March 7, 2011, is whether Congress can remove works from the public domain.

Section 201(a)(1) of the JOBS Act directs the SEC to remove the prohibition on general solicitation or general advertising for securities offerings.

The Texas Business Organizations Code offers a unique option to divide the assets of a Texas company called a divisional or divisive merger...

FDA's proposed Draft Guidance setting an "action level" for arsenic in apple juice does not mean the FDA found dangerous levels of arsenic in apple juice.

As the restaurant industry works to comply with the law, the Food and Drug Administration remains at the drawing table trying to figure out how to draft the rules.

The absence from the state of Texas of a person against whom a cause of action may be maintained suspends the running of the applicable statute of limitations for the period of the person's absence.

On July 3, the Supreme Court provided an analytical framework for determining whether spoliation has occurred, and if so, what remedies are available.

On January 10, 2014, the Food and Drug Administration issued a Draft Guidance entitled "Fulfilling Regulatory Requirements for Postmarketing Submissions of Interactive Promotional Media for Prescription Human and Animal Drugs and Biologics."

Just before Thanksgiving the Texas Supreme Court adopted revised rules of evidence. But no fear, the revisions are almost entirely stylistic.

Since the North American Free Trade Agreement ("NAFTA") took effect on January 1, 1994, the United States has been obligated to phase in U.S. market access for Mexico-based trucking companies.

FDA capitulates, dropping a meritless enforcement action against Pacira and putting off Amarin until February 17, 2016.

More than ten years after the District Court in DC invalidated FDA regulations concerning promotional activities as violative of the First Amendment to the US Constitution in Washington Legal Foundation v. Henney, and as the judge who presided over that case predicted, the First Amendment challenge to FDA regulations prohibiting truthful and non-misleading speech has resurfaced.