FDA Archives

MoCRA: The Future of Cosmetic Regulations

Drug & Biologic Product Submissions, Drug Label Research, Pharmaceutical

The Modernization of Cosmetics Regulation Act of 2022 (MoCRA) was signed into law on December 29, 2022. This law, which provides a major overhaul of existing cosmetic regulations, requires the Food and Drug Administration (FDA) to create Good Manufacturing Practices for all cosmetics manufacturers. The law states that these established practices must include mandatory reporting of serious adverse health events caused by cosmetic products and mandatory testing of asbestos levels. This law will also include updates to cosmetic listing requirements.

Missed FDA Annual Deadlines? It’s not too late to keep your drug active!

Drug & Biologic Product Submissions, Pharmaceutical

The Food and Drug Administration (FDA) requires drug manufacturers to keep their listings updated each year. Most of the deadlines fall on December 31st. What happens if a manufacturer misses these deadlines? In most cases, the drug is in danger of becoming...

New FDA Requirement: New and Updated REMS Files to be Submitted in SPL Format

Drug & Biologic Product Submissions, Pharmaceutical

As of December 28, 2022, all new REMS (Risk Evaluation and Mitigation Strategy) submissions and all REMS updates will be required to be submitted in SPL (Structured Product Labeling) format per the FDA. This is in compliance with the Final Guidance on REMS issued by...

Easy Drug Product Searches in Early-Stage Drug Concept and Discovery

Drug & Biologic Product Submissions, Drug Label Research, Pharmaceutical

During early-stage drug concept and discovery, Pharmaceutical companies will find it necessary to research the market for existing drug products for any number of reasons. These reasons can vary greatly depending on factors such as if the drug is Rx, OTC or biologic...

FDA Drug Distribution Amounts Report: Frequently Asked Questions and More

Drug & Biologic Product Submissions, Pharmaceutical

In late 2021, the US Food and Drug Administration (FDA) is instited a new annual distribution report, Reporting Amount of Listed Drugs and Biological Products Under Section 510(j)(3) of the Federal Food, Drug, and Cosmetic Act, for all listed drugs. According to...

Public Dashboard Now Available for REMS Data

Drug & Biologic Product Submissions, Pharmaceutical

A new public dashboard has been launched by the Food and Drug Administration (FDA) for public access to data for drugs with approved Risk Evaluation and Mitigation Strategy (REMS.) According to FDA, This new dashboard includes visualizations and charts for total and...

Updated Deadline: FDA Announces New Annual Drug Distribution Reporting Requirement

Drug & Biologic Product Submissions, Pharmaceutical

The Food and Drug Administration (FDA) has informed industry that the February 15, 2022 date for submitting 2020 data per Reporting Amount of Listed Drugs and Biological Products Under Section 510(j)(3) of the Federal Food, Drug, and Cosmetic Act, originally referred...

Proposed Changes to OTC Sunscreen GRASE and Labeling Regulations

Drug & Biologic Product Submissions, Life Sciences, Pharmaceutical

The FDA has proposed new changes to the regulations regarding over-the-counter sunscreen products. Perhaps the most impactful change to manufacturers, the FDA seeks to significantly decrease the ingredients that are generally recognized as safe and effective (GRASE)...

OTC Monograph Fees Announced… Not so fast!

Drug & Biologic Product Submissions, Pharmaceutical

Co-Authored by David Wilson, Sr. Account Executive, Reed Tech, and Carolina Wirth, Of Counsel, Arnall Golden Gregory, LLP On December 29, 2020, the U.S. Food and Drug Administration published a Federal Register notice setting the fee rates under the Over-the-Counter...

Ensure Imports are Not Detained Due to FDA Non-Compliance

Drug & Biologic Product Submissions, Life Sciences, Pharmaceutical

In the final webinar of 2020, Reed Tech invited an expert attorney to discuss import compliance and how it ties into FDA compliance. David Wilson, Reed Tech, and Jennifer Diaz, Esq., Diaz Trade Law, discussed many topics ranging from compliant importation and FDA...

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Recent Blogs

MoCRA: The Future of Cosmetic Regulations

Missed FDA Annual Deadlines? It’s not too late to keep your drug active!

New FDA Requirement: New and Updated REMS Files to be Submitted in SPL Format

Easy Drug Product Searches in Early-Stage Drug Concept and Discovery

FDA Drug Distribution Amounts Report: Frequently Asked Questions and More

Public Dashboard Now Available for REMS Data

Updated Deadline: FDA Announces New Annual Drug Distribution Reporting Requirement

Proposed Changes to OTC Sunscreen GRASE and Labeling Regulations

OTC Monograph Fees Announced… Not so fast!

Ensure Imports are Not Detained Due to FDA Non-Compliance

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