Advertising Archives - Lachman Consultant Services, Inc.

Guidance Gives Firms More Tools to Deal with Misinformation - Lachman Blog

Revised Q&A Guidance Gives Firms More Tools to Deal with Misinformation – Or Does It?

By Bob Pollock Jul 11, 2024 Advertising Compliance Labeling Regulatory Affairs

The FDA has just revised a guidance titled, “Addressing Misinformation About Medical Devices and Prescription Drugs: Questions and Answers” (here) which says: “This revised draft guidance, when finalized, will describe FDA’s current thinking on common questions firms may have when voluntarily addressing misinformation about or related to their approved/cleared medical products. This guidance revises and […]

Apr

Revised Q&A Document on Promotional Activities for Biosimilars Released by FDA

By Bob Pollock Apr 24, 2024 Advertising Biologics Biosimilars Labeling Promotional material Regulatory Affairs

Today, the FDA released a draft guidance titled Promotional Labeling and Advertising Considerations for Prescription Biological Reference Products, Biosimilar Products, and Interchangeable Biosimilar Products: Questions and Answers (here). Try saying that without taking a breath! This draft is a revision of the initial draft guidance issued on February 4, 2020 (85 FR 6201) (the 2020 draft guidance). The […]

Nov

Prescription Drug Advertising – Final Rule Issued on DTC Ads

By Bob Pollock Nov 20, 2023 Advertising DTC Labeling NDA

I am sure that any of you that have listened to radio or watched TV have heard a prescription drug ad and have struggled with keeping up with the fast talking and not so slow walking people, scene, or scrolling of text on direct-to-consumer ads. FDA has been working to develop standards over the course […]

Jan

FTC Issues Newly Revised Health Product Compliance Guidance – How About That!

By Bob Pollock Jan 11, 2023 Advertising Dietary Supplements FTC Homeopathic Drugs OTC Regulatory Affairs

Just one day after expressing my opinion that more needs to be done to enhance dietary supplement regulations and requirements, I found that the FTC recently revised an older guidance (from 1998) entitled Dietary Supplements: An Advertising Guide for Industry. The new guidance entitled Health Product Compliance Guidance (here), was issued on December 20, 2022 […]

Feb

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Promotional Labeling is the Target of New Q&A Document on Biosimilars and Reference Products

By Bob Pollock Feb 03, 2020 Advertising Biologics Biosimilars BLA Labeling Promotional material

Today, the FDA released a guidance document titled Promotional Labeling and Advertising Considerations for Prescription Biological Reference and Biosimilar Products: Questions and Answers (here). The document provides the FDA’s responses to eight questions designed to help firms assure that they do not run afoul in advertising or promotion when describing similarities and differences between the […]

Nov

Hope at This Time of Giving Thanks

By Bob Pollock Nov 26, 2019 505(b)(2) Abuse deterrent Accelerated Approval Advertising Analytical Methods ANDAs Approvals Bioanalytical Bioequivalence Biologics Biosimilars BLA Brand Name Drugs Bulk Drugs List CBER CDER Chemistry Clinical CMC Combination Products Complex Generics Compliance Compounders Compounding Controlled correspondence CVM Data Integrity DEA Device Dietary Supplements Drug Pricing Drug Shortages eCTD Emerging Technology Enforcement Exclusivity FDA FDA First Generics Foods GDUFA Fees Generics Guidance Homeopathic Drugs ICH Imports International Label Changes Labeling Laboratories Manufacturing Medical Devices NDA New Drugs OGD Opioids OTC Petitions PMA Post Approval projectsnowflake Receipts Regulatory Affairs Safety Science & Technology Shortages Training Uncategorized User Fees Validation

Just look around, watch the television, read the newspaper, and what do you see? Seems like very few reasons to be thankful. School and workplace shootings, the political scene is as nasty as I ever remember in my 70 years on earth. Climate change is threatening the future of our children, and the environmental controls […]

May

Accelerated Approval and DTC Advertising – FDA Proposes a Study to Inform Which Direction to Take

By Bob Pollock May 07, 2019 Advertising FDA NDA Regulatory Affairs

In the Federal Register (FR) pre-publication page (here) today, FDA announced a proposed study to evaluate patient/consumer ability to understand the impact of Direct to Consumer (DTC) advertising for products with accelerated approvals. These products are typically approved based on a surrogate endpoint (such as a blood test) that has a reasonable likelihood to predict […]