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Regulatory Due Diligence Becomes More Critical in a “Hot” Year for Deals in the FDA Space

FDA Law Blog

In a “hot” deal market, its worthwhile reiterating the fundamentals of regulatory due diligence that don’t change, no matter how attractive the deal or how short the window is to seize the opportunity. Having the right diligence team is critical because proper risk assessment of regulatory risk requires a broad range of expertise.

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Supreme Court limits scope of anti-bribery law

SCOTUSBlog

Writing for a six-justice majority, Justice Brett Kavanaugh explained that state and local governments already regulate gifts to officials, and so the federal law “does not supplement those state and local rules by subjecting 19 million state and local officials to up to 10 years in federal prison for accepting even commonplace gratuities.”

Laws 110
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Justices will consider equitable tolling for a veteran suffering from PTSD

SCOTUSBlog

Arellano appealed, requesting that the timetable in the controlling statute, 38 U.S.C. Court of Appeals for the Federal Circuit, sitting en banc, unanimously found that equitable tolling is not available to Arellano, but was split on whether the statute could be equitably tolled. In Irwin v.

Statute 105
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Beards and Brady (i.e., religious freedom and criminal procedure)

SCOTUSBlog

Under RLUIPA, the government may not “impose a substantial burden on the religious exercise of a person residing in or confined to an institution,” unless the government proves the restriction is “in furtherance of a compelling governmental interest” and is “the least restrictive means of furthering” that government interest.

Diligence 103
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Supreme Court Rules Bribery Statute Doesn’t Criminalize Gratuities for Past Acts

Constitutional Law Reporter

As enacted in 1984, the statute at issue in the case, 18 U.S.C. Justice Kavanaugh cited that six reasons that, taken together, led the Court to conclude that §666 is a bribery statute and not a gratuities statute—”text, statutory history, statutory structure, statutory punishments, federalism, and fair notice.”

Statute 52
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Equitable tolling in a corner of the Internal Revenue Code

SCOTUSBlog

The government argued that Section 6330(d)(1) is jurisdictional, so that equitable tolling – the legal principle that allows courts to “toll,” or extend, deadlines in some circumstances – would not apply under Irwin v. It held instead that the statute is not jurisdictional, and that equitable tolling is an available argument in Tax Court.

Statute 100
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In Uncertain Times, Good Compliance and Quality Communication Habits Can Offer a Port in the Storm

FDA Law Blog

With all the change we are witnessing in the American model of regulation and governance, it might be tempting to ask if we are suddenly living in a post-compliance word. How will the imposition of tariffs and a burgeoning trade war affect domestic drug production and companies supply chain demands?