Labeling Archives - Page 4 of 4 - Lachman Consultant Services, Inc.

Don’t Get a Swelled Head, Feeding Tube Guidance Straightens Out Requirements

By Bob Pollock Jun 02, 2021 ANDAs FDA Labeling Regulatory Affairs Science & Technology

Today, the FDA released its draft guidance entitled Oral Drug Products Administered Via Enteral Feeding Tube: In Vitro Testing and Labeling Recommendations Guidance for Industry (here). There have been numerous cases of clogging or otherwise blocking of enteral naso-gastric (N-G) feeding tubes when medication is administered due to a number of different reasons: swelling of […]

May

Maybe This Is the Year for E-labeling?

By Bob Pollock May 07, 2021 ANDAs BLA FDA Generics Labeling Medical Devices NDA

Just nine (9) days ago, I posted a blog and article (here) on the issue of paper prescribing information – package inserts! The overall takeaway was that FDA is ready to move on this issue. There was a proposed rule sitting dormant, because every year since its proposal, e Congress has included a provision in […]

Apr

Paper Inserts for Prescription Drugs – a Dinosaur That Won’t Go Away

By Bob Pollock Apr 23, 2021 Brand Compliance FDA Generics Labeling

An article in STAT (here) (paid subscription required), authored by a former FDAer, Jane Axelrad, should be read by all in the pharmaceutical industry. Axelrad notes that, while online access to current prescribing information has been available for over fifteen years, progress in eliminating the requirement to provide paper labels has been stymied by paper […]

Jul

Proposed Law Would Provide pathway for Generic Drugs Labeling Changes with a Reasoned Approach

By Bob Pollock Jul 20, 2020 ANDAs FDA Generics Labeling Regulatory Affairs

Proposed Law Would Provide Pathway for Generic Drugs Labeling Changes with a Reasoned Approach Proposed H.R. 5668 (here) titled, Making Objective Drug Evidence Revisions for New Labeling Act of 2020, outlines a path forward for making generic drug labeling changes when the reference listed drug is no longer marketed. We all understand the history of […]

Feb

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FDA and FTC Announce a Coordinated Plan for Advancing Competition in the Biologic Drug Marketplace

By Keith Webber Feb 05, 2020 Bioequivalence Biologics Biosimilars BLA Compliance Enforcement FDA Labeling Regulatory Affairs

The Food and Drug Administration (FDA) and the Federal Trade Commission (FTC) issued a joint statement on Monday, February 3, 2020 (here) regarding their collaborative plans to advance competition in the biologics market. This joint effort is intended to address misinformation and anti-competitive behavior that may impede competition between biologic drug products. A significant focus […]

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 […]

Aug

Child-Resistant Packaging – The FDA Outlines What and How to Label Products

By Bob Pollock Aug 14, 2019 ANDAs BLA FDA Generics Labeling NDA OTC Regulatory Affairs

In a Federal Register announcement today (here), the FDA announced the availability of a final guidance entitled Child-Resistant Packaging Statements in Drug Product Labeling. The guidance provides information on the type of statement that may be made on child-resistant packaging for drug products. As a reminder, the FDA has not regulated child-resistant packaging since 1973, […]

Jul

Potential Label Carve Out to Antidepressant Appears OK to FDA

By Bob Pollock Jul 23, 2019 FDA Generics Labeling Petitions Regulatory Affairs

In a 21 page response (here) dated July 18, 2019 to Citizen Petition Docket No. 2019-P-0837 (here ), filed on February 20, 2019, the FDA determined that a carve out of an exclusivity-based and patent-based (potential little viii) statements regarding a supplemental application approval granting the inclusion of information on treatment of emergent sexual dysfunction […]