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Biotechnology › Rulemaking Process

Bergeson & Campbell, P.C.

APHIS Evaluates Petitions Reviewed under 2012 Process, Will Use Process Consistent with USDA Biotechnology Regulations Going...

Bergeson & Campbell, P.C. on

The U.S. Department of Agriculture’s (USDA) Animal and Plant Health Inspection Service (APHIS) announced on March 27, 2025, that it will no longer use the process it outlined in 2012 for reviewing petitions seeking a...more

Hogan Lovells

A bit more Sunshine: CMS proposes collecting additional information on manufacturer payments under the Open Payments program

Hogan Lovells on

Device and drug manufacturers got a small surprise in the annual Physician Fee Schedule proposed rule (at 40,713-16) issued late in July by the Centers for Medicare & Medicaid Services (CMS) – among many other things, the...more

Hogan Lovells

Will FDA be forced to implement a drug importation program?

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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

Hogan Lovells

FDA publishes final guidance on ANDA/505(b)(2) NDA pathways

Hogan Lovells on

On Thursday, FDA published the final guidance document, “Determining Whether to Submit an ANDA or a 505(b)(2) Application” that contains minor revisions to the October 2017 draft guidance. ...more

Hogan Lovells

With the Statutory Deadline Approaching, FDA Issues a Proposed Sunscreens Rule

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On February 26, FDA published the proposed rule, “Sunscreen Drug Products for Over-the-Counter Human Use,” which describes the conditions under which Over-the-Counter (OTC) sunscreen monograph products are generally...more

McDonnell Boehnen Hulbert & Berghoff LLP

Examination of Myriad-Mayo Guidance Comments -- International Bioindustry Associations

McDonnell Boehnen Hulbert & Berghoff LLP on

On March 4, the U.S. Patent and Trademark Office issued a guidance memorandum, entitled "Guidance For Determining Subject Matter Eligibility Of Claims Reciting Or Involving Laws of Nature, Natural Phenomena, & Natural...more

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