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The FDA recently announced that it has reached a tentative agreement with the medical device industry (represented through trade associations) on user fees, performance goals, and other matters for the period 2013-17.

The FDA recently issued a draft Guidance document titled "Medical Devices: Pre-Submission Program and Meetings with FDA Staff" (the "Guidance") to provide advice to medical device manufacturers who want FDA’s input before submitting an IDE, HDE, 510(k), or PMA.

FDA recently issued a draft Guidance interpreting "substantive summary" and "significant decision" as used in section 603.

Part of what the medical device industry bought with the substantial increase in FDA user fees to which it agreed in the FDA Safety and Innovation Act of 2012 was an independent review and evaluation of FDA’s primary premarket device review programs, the 510(k) and PMA programs.

The FDA recently issued a final guidance titled, "The 510(k) Program: Evaluating Substantial Equivalence in Premarket Notifications."

Section 603 of FDASIA required FDA to furnish, upon request, a "substantive summary of the scientific and regulatory rationale for any significant decision."

The FDA recently issued a final Guidance document titled "Medical Devices: Pre-Submission Program and Meetings with FDA Staff" to provide advice to medical device manufacturers who want FDA’s input before submitting an IDE, HDE, 510(k), or PMA.

On October 20, 2011, the Center for Medicare and Medicaid Services (CMS) and the Department of Health and Human Services Office of Inspector General (OIG) released an Interim Final Rule (OIG Rule) providing fraud and abuse waivers for accountable care organizations (ACOs) that participate in the Medicare Shared Savings Program (Shared Savings Program).

The U.S. Court of Appeals for the Third Circuit recently issued a non-precedential opinion affirming a finding that alleged food labeling claims asserted against Johnson & Johnson were expressly preempted by the Food, Drug & Cosmetic Act.

On Oct. 30, President Joe Biden signed the Executive Order on the Safe, Secure, and Trustworthy Development and Use of Artificial Intelligence, an initiative designed to position the United States...

U.S. higher education is widely recognized as the entity that molds bright minds, many of which proceed to innovate and discover, transforming society for the better.

Effective September 6, 2025, DOS has announced that nonimmigrant visa (NIV) applicants must schedule their visa interviews at the U.S. embassy or consulate in their country of nationality or residence.

Among the multiple executive actions the White House announced on June 18, 2024, was one stating it was taking steps to facilitate the process for certain Deferred Action for Childhood Arrivals (DACA)...

The Citizenship and Immigration Service (CIS) has announced that a new version of the Form I-129 will go into effect on Nov. 23, 2010. This affects users of H-1B, H-1B1 (Chile/Singapore), L-1 and O-1A petitions only.

U.S. Citizenship and Immigration Services (USCIS) recently announced its intention to launch online organizational accounts, making Form I-129, the form used for H-1B and other employment-based...

On Dec. 29, 2008, the United States Court of Appeals for the Federal Circuit issued a writ of mandamus holding that a district court judge in the Eastern District of Texas abused his discretion in denying a defendant's motion to transfer venue to a more convenient forum in Ohio.

The pharmaceutical industry is approaching one of the most consequential inflection points in its modern history. By 2027, patent expirations on a wave of blockbuster drugs will expose approximately $150 billion in annual revenue to generic and biosimilar competition — a reckoning that is already reshaping how companies build, defend, and monetize their intellectual property.