News & Analysis as of

Prescription Drugs › Abbreviated New Drug Application (ANDA) › Draft Guidance

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FDA issued a draft guidance that lays the groundwork for drug companies to comply with changes to approved color additives....more

Arnall Golden Gregory LLP

All Mixed Up: FDA Issues Two Guidances Relating to Compounding Using Bulk Drug Substances

Arnall Golden Gregory LLP on

When we think of compounding, which is the process of combining, mixing, or altering ingredients to create a medication specific to the needs of an individual patient, we think of the Cars’ 1978 classic, “It’s All Mixed Up.”...more

King & Spalding

FDA Ushers in New Program for Drug Products Manufactured Using Innovative Manufacturing Technologies

King & Spalding on

Under Section 3213 of Food and Drug Omnibus Reform Act, the U.S. Food & Drug Administration (“FDA” or the “Agency”) is required to establish the Advanced Manufacturing Technologies Designation Program, an initiative intended...more

King & Spalding

FDA Issues Draft Guidance for Obtaining Postmarket Data on Underrepresented Populations in Drug Clinical Trials

King & Spalding on

The Food and Drug Administration (FDA) has issued new draft guidance, Postmarketing Approaches to Obtain Data on Populations Underrepresented in Clinical Trials for Drugs and Biological Products (the Draft Postmarketing...more

Hogan Lovells

FDA draft guidance addresses complexities in establishing active ingredient sameness in an ANDA

Hogan Lovells on

The U.S. Food and Drug Administration (FDA) recently published the draft guidance “Sameness Evaluations in an ANDA – Active Ingredients,” which aims to assist applicants preparing an abbreviated new drug application (ANDA) by...more

McDonnell Boehnen Hulbert & Berghoff LLP

FDA Releases Draft Guidance on Evaluation of Therapeutic Equivalence of Approved Biologic and Small Molecule Drugs

McDonnell Boehnen Hulbert & Berghoff LLP on

On July 20th, the FDA released draft Guidance regarding its standards on therapeutic equivalence (TE) between both biologic and small molecule (NCE) drugs.  The definition of "therapeutic equivalence" in the Guidance is...more

Wilson Sonsini Goodrich & Rosati

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

Wilson Sonsini Goodrich & Rosati on

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

K&L Gates LLP

K&L Gates Triage: REMS…Sharing is so hard to do

K&L Gates LLP on

The U.S. Food and Drug Administration (FDA) recently released two draft guidance documents related to its requirement for shared risk evaluation and mitigation strategies (REMS) and the process for requesting a waiver of this...more

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