News & Analysis as of

Supply Chain Healthcare Reform

Manatt, Phelps & Phillips, LLP

FDA Approves Florida’s Application to Import Drugs from Canada

On January 5, 2024, the Food and Drug Administration (FDA) authorized the state of Florida’s proposal under the Section 804 Importation Program (SIP) for a period of two years. FDA’s action marks the first time a state drug...more

Hogan Lovells

FDA expands mutual reliance and harmonization with trusted foreign regulators for inspectional oversight - PIC/S GMP guide aims to...

Hogan Lovells on

The U.S. Food and Drug Administration’s (FDA) commitment to expand mutual reliance with trusted regulatory partners may be a silver lining for biomedical innovation during an unprecedented public health emergency. ...more

Morgan Lewis

What the Future May Hold for Pharma Regulation Under the Biden Administration

Morgan Lewis on

Under President Joe Biden, pharmaceutical regulation may see increased FDA guidance, new strategies to speed up innovation and regulatory review, and a renewed focus on diseases with unmet needs, among other expectations....more

Polsinelli

How Washington’s Power Shift Could Impact Health Care

Polsinelli on

Following President Joe Biden’s inauguration, Democrats control the executive and legislative branches of government for the first time in 10 years. Democrats presently have a three-seat majority in the House while Democratic...more

Akin Gump Strauss Hauer & Feld LLP

What's New in Washington - January 2021

As Senators-elect Reverend Raphael Warnock and Jon Ossoff are sworn-in after certification of the Georgia elections, Democrats are poised to assume the majority in the Senate, which, along with their control of the White...more

Hogan Lovells

Will FDA be forced to implement a drug importation program?

Hogan Lovells on

Over a year ago, HHS Secretary Alex Azar requested that FDA establish a working group to explore how drug importation “could help address price hikes and supply disruptions.” The FDA working group was not assigned the task of...more

King & Spalding

Also In The News - Health Headlines - July 2015

King & Spalding on

CMS Reopens Attestation Period For First-Time Hospitals Until August – CMS recently announced that eligible hospitals participating in the Medicare Electronic Health Record Incentive Program for the first time in 2015 may...more

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