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Government Agencies
New AAFP President to Focus on Administrative Burden
Michael Munger, MD, recently assumed the role of president of the American Academy of Family Physicians (AAFP). During his opening…
FDA Guidances Being Issued Slower than Expected
We found an interesting Regulatory Focus story on the lack of FDA guidance documents since the start of President Trump’s tenure…
AbbVie Found Liable for Misrepresentation in AndroGel Case
In July 2017, a Chicago jury found AbbVie Inc. guilty of fraudulently misrepresenting the risks of its testosterone replacement…
CDER 2017 Guidance Agenda
In January, FDA’s Center for Drug Evaluation and Research (CDER) released its annual guidance agenda, announcing the new and…
Trump Executive Order Targets Regulations
On one of his first few days on the job, President Donald Trump signed an executive order that would require all government…
OIG Issues Semiannual Report to Congress
The Department of Health and Human Services (HHS) issued its Semiannual Report to Congress, covering April 1, 2016 to September…
21st Century Bill Headed to President Obama’s Desk
Nearly three years after its initial introduction, the 21st Century Cures Act has finally passed both houses of the Congress, and…
Leahy, Wyden Send Letter to DOJ Regarding DEA Enforcement Actions
Recently, the ranking members of the Judiciary and Finance Committees, Senators Patrick Leahy and Ron Wyden, respectively, raised…
Willis-Knighton Antitrust Suit Allowed to Proceed
Consolidation is happening in insurers and health systems throughout the country. A recent legal case in Louisiana sheds…
Court Strikes Down HRSA’s 340B Orphan Drug Policy, Again
In October, a federal court struck down a Health Resources and Services Administration 340B orphan drug policy (the…