News & Analysis as of

Drug Pricing Draft Guidance Food and Drug Administration (FDA)

Latham & Watkins LLP

FDA Color Additive Scrutiny Expands to Pharmaceuticals

Latham & Watkins LLP on

FDA issued a draft guidance that lays the groundwork for drug companies to comply with changes to approved color additives....more

King & Spalding

Administrative, Congressional, and State Interest Signal a Potential Breakthrough Moment for Psychedelics

King & Spalding on

The development of innovative pharmaceuticals targeting refractory mental health conditions has stagnated for decades. In recent years, however, psychedelics have garnered scientific and public attention for their potential...more

Akin Gump Strauss Hauer & Feld LLP

FDA Unveils Draft Guidance on Developing Drugs and Biological Products for Weight Reduction

On January 7, the FDA made available draft guidance on the development of drugs and biological products for weight reduction within the Center for Drug Evaluation and Research intended for reduction and long-term maintenance...more

Sheppard Mullin Richter & Hampton LLP

The March on Pharmaceutical Patents?

December 7, 2023, President Biden announced new actions to promote competition in health care and to lower prescription drug costs. Of particular note is a newly unveiled framework for deciding whether the Government may...more

Sheppard Mullin Richter & Hampton LLP

Charging for Investigational Drugs Under an IND Questions and Answers, Draft Guidance for Industry, August 2022

Providing further clarification to drug manufacturers about specific costs that can be charged for investigational drugs used in clinical and expanded access trials...more

McGuireWoods Consulting

Washington Healthcare Update - November 2021 #2

This week in Washington: Congressional Democrats reach drug pricing agreement; bipartisan infrastructure bill goes to President Biden’s desk with budget reconciliation bill delayed....more

King & Spalding

FDA Issues Proposed Rule and Draft Guidance on Drug Importation

King & Spalding on

In late December 2019, the Food and Drug Administration (FDA), an agency operating within the Department of Health and Human Services (HHS), issued two documents—a Proposed Rule and a Draft Guidance—intended to establish two...more

Wilson Sonsini Goodrich & Rosati

FDA Issues Competitive Generic Therapies (CGTs) Statement and Guidance Regarding CGT Designation, Approval Pathway, and Market...

Recently, the United States Food and Drug Administration (FDA) Commissioner Scott Gottlieb issued a statement (the statement) outlining a new policy to improve access and foster price competition for branded drugs that are...more

Arnall Golden Gregory LLP

FDA Issues Draft Guidance with Recommendations on Presenting Quantitative Efficacy and Risk Information in Direct-to-Consumer...

On October 17, 2018, the Food and Drug Administration published a draft guidance for industry on “Presenting Quantitative Efficacy and Risk Information in Direct-to-Consumer Promotional Labeling and Advertisements.” ...more

Knobbe Martens

China Drug Administration Proposes Pharmaceutical Data Protection Guidelines

Knobbe Martens on

On April 26, 2018, the China Drug Administration (CDA) released a draft guideline of implementing rules on pharmaceutical data exclusivity for public comments. The draft guideline expands the scope of data protection from...more

Mintz - Health Care Viewpoints

Senators to Receive Update on Biosimilar Implementation from CDER’s Woodcock

On September 17, 2015, members of the Senate Health, Education, Labor & Pensions (HELP) Committee will have an opportunity to hear from and question Dr. Janet Woodock, the director of FDA’s Center for Drug Evaluation and...more

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