FDA Archives

FDA Issued Final Guidance on Over-the-Counter Monograph Submissions in Electronic Format

Drug & Biologic Product Submissions, Featured, Life Sciences, Pharmaceutical and Cosmetics

The FDA has issued the final guidance “Providing Over-the-Counter Monograph Submissions in Electronic Format.” This new guidance mandates electronic submission of all Over-the-Counter (OTC) monograph materials, marking a significant shift in the regulatory landscape. By transitioning to electronic submissions, the FDA has expressed aim to streamline the review process, enhance transparency and facilitate faster decision-making for OTC drug approvals.

Reg Ops Radar: eCTD & Regulatory Updates

Life Sciences, Pharmaceutical and Cosmetics

Industry is currently seeing rapid changes and improvements to existing eCTD formats, requirements and suggested uses from FDA. Here at LexisNexis Reed Tech, we want to be sure that our customers are not only up-to-date with, but understand, these new developments. To support this knowledge share, our in-house team of eCTD experts will be offering insights on a regular cadence this summer.

July 31st Deadline Approaching for CARES Act Report

Drug & Biologic Product Submissions, Featured, Pharmaceutical and Cosmetics

The FDA CARES Act requires drug manufacturers, repackers and relabelers to submit annual reports on drug production volumes. Here are the key points: Deadline: July 31, 2024, for the 2023 calendar year; Who Must Report: All FDA-registered facilities under section 510(j)(3) of the Federal Food, Drug & Cosmetic Act; What to Report: Annual production volumes for each listed drug.

Market Research in Early-Stage Drug Concept and Discovery

Drug & Biologic Product Submissions, Drug Label Research, Pharmaceutical and Cosmetics

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 Plans for Artificial Intelligence and Medical Products

Life Sciences, Medical Devices, Pharmaceutical and Cosmetics

AI has the potential to revolutionize healthcare, and the FDA wants to ensure that patient safety remains the top priority while fostering these cutting-edge advancements. That’s where their four areas of focus come in – collaboration, regulatory clarity, standards and best practices and research.

MoCRA’s Impact on Private Label Cosmetic Manufacturers: Navigating the New Era of Beauty Compliance

Life Sciences, Pharmaceutical and Cosmetics

The Modernization of Cosmetics Regulation Act (MoCRA) is here, and it’s about to shake up the industry. As the FDA gears up to implement MoCRA by July 2024, it’s time for private label manufacturers to get their ducks in a row and embrace the new era of beauty compliance.

FDA Releases Drug Amount Report Final Guidance and Updated Deadlines

Life Sciences, Pharmaceutical and Cosmetics

After an 829 day wait from the initial draft guidance, the FDA has issued the long-awaited Final Guidance on Reporting Amount of Listed Drugs and Biological Products Under Section 510(j)(3) of the Federal Food, Drug, and Cosmetic Act – or as Reed Tech has taken to...

2024 MoCRA Update: Delays, Enforcement and More

Life Sciences, Pharmaceutical and Cosmetics

As the first US cosmetic regulation in over 80 years is finally being implemented, Reed Tech is keep a close eye on all evolving mandates, requirements and deadlines to communicate all relevant information to our customers. As such, Reed Tech subject-matter experts,...

MoCRA Submission Encouraged by Dec. 29, 2023; Enforcement Delayed

Drug & Biologic Product Submissions, Pharmaceutical and Cosmetics

On November 8, 2023, the Food and Drug Administration (FDA) announced that it will be ready to accept registration and listing information for the Modernization of Cosmetics Regulation Act of 2022 (MoCRA) by the statutory deadline of December 29, 2023 and encourages companies to meet that deadline.

Navigating the AusUDID Rollout: A New Era for Medical Device Identification

Medical Devices, Unique Device Identification

Explore the significance of the AusUDID rollout, its objectives, and how the TGA requirements for UDI differ from FDA regulations.

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FDA Issued Final Guidance on Over-the-Counter Monograph Submissions in Electronic Format

Reg Ops Radar: eCTD & Regulatory Updates

July 31st Deadline Approaching for CARES Act Report

Market Research in Early-Stage Drug Concept and Discovery

FDA Plans for Artificial Intelligence and Medical Products

MoCRA’s Impact on Private Label Cosmetic Manufacturers: Navigating the New Era of Beauty Compliance

FDA Releases Drug Amount Report Final Guidance and Updated Deadlines

2024 MoCRA Update: Delays, Enforcement and More

MoCRA Submission Encouraged by Dec. 29, 2023; Enforcement Delayed

Navigating the AusUDID Rollout: A New Era for Medical Device Identification

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