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Michael Taylor, the head of FDA’s Center for Food Safety and Nutrition, recently announced that by early summer the FDA intends to issue revised versions of two of its pending food safety rules.

The FDA recently issued a draft Guidance titled, "The 510(k) Program: Evaluating Substantial Equivalence in Premarket Notifications." The draft Guidance states that its purposes are "to identify, explain, and clarify each of the critical decision points in the decision-making process FDA uses to determine substantial equivalence" and "to enhance the predictability, consistency, and transparency of the 510(k) program by describing in greater detail the regulatory framework, policies, and practice

The explosive growth of internet pharmacies and direct-to-consumer shipment of pharmaceuticals has provided increased access to, and reduced the cost of, important medications.

In an effort to increase access to health insurance, Congress designed the exchanges as online portals where individuals could compare and enroll in plans offering certain benefits and meeting other requirements.

The Indiana Supreme Court has determined that terminated county employees do not have the right to sue county commissioners to obtain judicial review.

The Citizenship and Immigration Service (CIS) implemented a revised Form I-129, (Petition For A Non-Immigrant Worker), which became effective on Dec. 23, 2010.

With the year end approaching, the DHS announced the impending implementation of a weighted selection process for cap-subject H-1B petitions to take effect on Feb. 27, 2026 in advance of the H-1B registration season...

On July 30, the U.S. Citizenship and Immigration Services (USCIS) announced it will conduct another drawing for the FY 2025 H-1B lottery.

In a closely-watched case that attracted several dozen amicus briefs, the Federal Circuit ruled en banc on Sept. 18 in SCA Hygiene Products AB v. First Quality Baby Products, No. 2013-1564...

The changes in the Inter Partes Review (IPR) process put in place over the last year have made IPR petitions a less favorable avenue in contesting patent validity. IPR proceedings were created by the America Invents Act (2011) to provide a faster, more efficient, and less expensive way to challenge the validity of issued patents outside traditional federal court litigation.

Effective June 4, 2025, the Trump Administration doubled the Section 232 tariffs on the imports of steel and aluminum from 25% to 50% from all countries...

The two cases Mark and Kian discuss in this episode each raise a tricky but important question.

State argues opt-in text messages fall outside new registration and bond requirements...

On Sept. 1, 2025, Texas Senate Bill 140 (SB 140) took effect, expanding the state's regulation of "telephone solicitations" to include SMS text messages.

The Bankruptcy Appellate Panel for the Sixth Circuit Court of Appeals recently issued an opinion of importance in bankruptcy cases involving commercial real estate as the debtor's only asset, such as a shopping center or office building.

The Treasury Department and the IRS have issued Final Regulations implementing the 3.8 percent tax on the investment income of certain "high income" individuals, estates, and trusts.

On Feb. 15, the Federal Aviation Administration (FAA) has released its long-awaited notice of proposed rules with respect to unmanned aircraft systems (UAS).