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Citizen Petitions Prescription Drugs

Rothwell, Figg, Ernst & Manbeck, P.C.

Boehringer Ingelheim Seeks to Redefine a Biosimilar’s “Strength”

On December 2, 2020, Boehringer Ingelheim Pharmaceuticals, Inc. (“Boehringer Ingelheim”) submitted a Citizen Petition requesting a change in the FDA’s interpretation of “strength” of biological products under the Biologics...more

Proskauer - Minding Your Business

H.R. 4712: A “Narrowly Tailored” Obligation Under the Orphan Drug Act?

The Orphan Drug Act provides two mechanisms by which a drug can receive an orphan drug designation for a “rare” disease: (1) if it affects less than 200,000 persons in the United States, or (2) if it “affects more than...more

Hogan Lovells

FTC backs FDA guidance intended to curtail citizen petition “shenanigans”

Hogan Lovells on

On Tuesday, December 4, the Federal Trade Commission (FTC) announced that it had submitted a comment regarding the Food and Drug Administration’s (FDA) revised draft guidance on citizen petitions. ...more

Foley & Lardner LLP

Three Dozen States Sue Makers of Opioid Addiction Treatment Medications for Antitrust

Foley & Lardner LLP on

With opioid abuse continuing to dominate national headlines, manufacturers of opioid overdose medications are facing intense scrutiny over pricing practices that threaten (or those perceived as threatening) public...more

Goodwin

GPhA Responds to PhRMA/BIO’s Joint Citizen Petition Regarding Biosimilar Labeling

Goodwin on

As we previously reported, in late 2015, the Pharmaceutical Research and Manufacturers of America (“PhRMA”) and Biotechnology Industry Organization (“BIO”) trade associations jointly submitted a Citizen Petition asking the...more

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