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Advertising and Promotion Considerations for Biologics, Biosimilars, and Interchangeables | Morgan Lewis - As Prescribed

FDA recently issued a revised draft guidance titled Promotional Labeling and Advertising Considerations for Prescription Biological Reference Products, Biosimilar Products, and...

Product-communications-that-are-consistent , Public-health-service-act , Advertising-considerations , Prescription-biological-reference-products , Biosimilar-products , Interchangeable-biosimilar , Product-communications-that-are-consistent-with , Required-labeling ,

FDA's Office Of Prescription Drug Promotion Issues Its First Untitled Letter Of The Year To Novartis For Misleading Statement Relating To KISQALI® - Food and Drugs Law

On January 18, 2024, the Office of Prescription Drug Promotion (OPDP) of the U.S. Food and Drug Administration (FDA) issued its first untitled letter of the new year to Novartis Pharmaceuticals Corporation...

Kisqali-qo , Drug-administration , Office-of-prescription-drug-promotion , Organization-for-research , Product-communications-that-are-consistent , Pharmaceuticals-corporation-novartis , Novartis , Prescription-drug-promotion , Pharmaceuticals-corporation , Consumer-prescription-drug-advertisements , Major-statement

FDA's Office of Prescription Drug Promotion Issues Its First Untitled Letter of the Year to Novartis for Misleading Statement Relating to KISQALI® | Sheppard Mullin Richter & Hampton LLP

On January 18, 2024, the Office of Prescription Drug Promotion (OPDP) of the U.S. Food and Drug Administration (FDA) issued its first untitled letter of the new year to Novartis...

Kisqali-qo , European-organization-for-research , Novartis-pharmaceuticals-corporation , Sheppard-mullin-richter-hampton , Office-of-prescription-drug-promotion , Drug-administration , Product-communications-that-are-consistent , Novartis , Sheppard-mullin-richter , Prescription-drug-promotion , Consumer-prescription-drug-advertisements

FDA Issues Letter to Novartis for Misleading Statement

FDA Issues Letter to Novartis for Misleading Statement
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Kisqali-qo , Drug-administration , European-organization-for-research , Office-of-prescription-drug-promotion , Product-communications-that-are-consistent , Novartis , Novartis-pharmaceuticals-corporation , Prescription-drug-promotion , Consumer-prescription-drug-advertisements , Major-statement , Neutral-manner

US Food and Drug Administration Off Label Space Activity

US Food and Drug Administration Off Label Space Activity
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Wisconsin , United-states , Communications-guidance , Pfizer , Office-of-prescription-drug-promotion , Product-communications-that-are-consistent , Althera-pharmaceuticals , Drug-administration , Supreme-court , Communications-guidance-signals-new-chapter , Draft-guidance

Beyond Reprints for Scientific Information on Unapproved Uses of Medical Products | King & Spalding

Revised Draft FDA Guidance Expands Scope of Permissible Proactive Off-Label Communications This week, FDA published new revised draft guidance, Communications From Firms...

Publication-for-health-care-providers , King-spalding , Device-manufacturer-communications , Public-health , Product-communications-that-are-consistent , Communications-guidance , Expands-scope , Permissible-proactive-off-label , Communications-from-firms , Unapproved-uses , Cleared-medical-products

FDA Sends a Strong Message About Efficacy Claims

FDA Sends a Strong Message About Efficacy Claims
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Letter-to-xeris-pharmaceuticals-inc , Office-of-prescription-drug-promotion , Letter-to-exeltis-united-states-inc , Product-communications-that-are-consistent , Drug-administration , Astrazeneca , Prescription-drug-promotion , Warning-letter , Breztri-promotional-aid , Triple-therapy , Obstructive-lung-disease

Context is Key: FDA Sends a Strong Message About Efficacy Claims | Sheppard Mullin Richter & Hampton LLP

On August 4, 2023, the Food and Drug Administration (“FDA”) Office of Prescription Drug Promotion (“OPDP”) issued a Warning Letter to AstraZeneca which stated that the company made...

Astrazeneca , Drug-administration , Letter-to-exeltis-united-states-inc , Office-of-prescription-drug-promotion , Letter-to-xeris-pharmaceuticals-inc , Sheppard-mullin-richter-hampton , Product-communications-that-are-consistent , Cytodyn-inc , Sheppard-mullin-richter , Prescription-drug-promotion , Warning-letter

FDA Imposes Its Weight and Puts the Load on a Drug Company for Unlawful Promotion | Arnall Golden Gregory LLP

We pay tribute in this Bulletin to the late Robbie Robertson of The Band, who penned the 1968 classic, “The Weight,” and the harmonic lyric, “You put the load right on me.” The Food...

Robbie-robertson , Drug-administration-office-of-prescription-promotion , Product-communications-that-are-consistent , Drug-administration , Prescription-drug-promotion , Warning-letter , Product-communications-that-are-consistent-with , Required-labeling ,

It's Not Just for Dietary Supplements Anymore: FTC Revises and Expands Guidance for Health Claims | King & Spalding

Signaling a renewed focus on consumer protection in the health claims space, the Federal Trade Commission (“FTC”) has revamped its 1998 guidance titled Dietary Supplements: An...

King-spalding , Instagram , National-institutes-of-health , Drug-administration , Health-apps , Health-products-compliance-guidance-federal-trade-commission , Sellers-of-health-products-federal-trade-commission , Product-communications-that-are-consistent , National-academy-of-sciences , Health-products-compliance-guidance-dec , Aura-labs-inc , Federal-trade-commission