NDA Archives - Page 10 of 25 - Lachman Consultant Services, Inc.

FDA Updates Draft Guidance on Required Notification of Discontinuance or Interruption in Manufacturing of Finished Products or Active Pharmaceutical Ingredients Under Section 506C of the FD&C Act

By Bob Pollock Apr 05, 2023 ANDAs API BLA Compliance Drug Shortages FDA NDA

The FDA is updating the draft guidance entitled, Notifying FDA of a Permanent Discontinuance or Interruption in Manufacturing Under Section 506C of the FD&C Act, that originally issued in March of 2020. As the drug shortage problem continues, this revised guidance (see here) is to better assist applicants and manufacturers in a process to provide […]

Nov

Accelerated Approvals – Here Is One to Watch

By Bob Pollock Nov 29, 2022 Accelerated Approval ANDAs FDA NDA Regulatory Affairs

It is always interesting to see how the Agency works when one action could trigger another action. In the Federal Register pre-publication page (here) this morning, the “Food and Drug Administration (FDA) [announced that it] is withdrawing approval of new drug application (NDA) 019832 for SULFAMYLON® (Mafenide Acetate, USP) Powder for 5% Topical Solution, held […]

Nov

OTC Naloxone Coming Down the Road? FDA Would Like to Think So!

By Bob Pollock Nov 15, 2022 FDA Nalaxone NDA OTC Regulatory Affairs

The opioid/fentanyl crisis, along with the abuse of other opioid‑based products, has put the prospect of an over‑the‑counter (OTC) version of naloxone high on the FDA’s priority list. Making the product available in a ready and easy‑to‑use format (for instance, a nasal spray or autoinjector) would increase the availability of this potentially life‑saving drug. Now, […]

Nov

Industry and Regulators Working to Prevent Drug Shortages

By Linda Evans O'Connor Nov 03, 2022 ANDAs Biologics Device FDA Industry NDA

I recently attended the ISPE Annual Meeting, held October 29 through November 2, 2022 in Orlando, Florida. The conference had varied content in areas such as Digital Transformation, Manufacturing Trends, Regulatory and Quality, Supply Chain Optimization, and Therapy Innovations. The conference was well attended by both industry and regulators. Although I found all of the […]

Nov

Convergence and Collaboration Themes at 2022 ISPE Annual

By Michele Sinoway Nov 03, 2022 ANDAs Biologics Device FDA Industry NDA

At the first highly attended ISPE Annual meeting since the pandemic hit, the themes that kept emerging from both sessions and attendees was convergence and collaboration. This concept reached its peak at the sessions that ended this conference, with a keynote from Peter Marks, MD/PhD, Director, CBER, FDA, the Regulatory Town Hall featuring representation from […]

Jul

Everything You May Want to Know About Therapeutic Equivalence (and More!)

By Bob Pollock Jul 20, 2022 ANDAs FDA NDA Regulatory Affairs Therapeutic equivalence

While most of us old timers grew up with Therapeutic Equivalence (TE) after the passage of Hatch-Waxman, the newly released draft guidance on TE (here) should be a good primer or refresher for most interested parties. There may also be some things you did not know, like how a 505(b)(2) application can request a TE […]

Jul

How to Prepare for an FDA Inspection – Important Things to Know, from the Perspective of a Former Investigator (Part 3)

By Webmaster Lachman Jul 05, 2022 ANDAs Compliance Drugs Enforcement Inspections NDA

In our previous installment on inspectional preparation and conduct, we covered recommended actions to be inspection ready, how to interact with FDA, and how personnel should conduct themselves during an FDA inspection. In today’s installment, we will cover what happens after the inspection, focusing on responding to an FDA 483 and inspectional outcome decision making. […]

Jul

How to Prepare for an FDA Inspection – Important Things to Know from the Perspective of a Former Investigator (Part 2)

By Webmaster Lachman Jul 01, 2022 ANDAs Compliance Drugs FDA Inspections NDA New Drugs Pharmaceutical industry Regulatory Affairs

In our previous installment, Tamil Arasu, former investigator with FDA, detailed preparations that a firm can make in advance of an FDA inspection, as well as details on the types of inspections that FDA performs on drug firms. In today’s post, Tamil will describe appropriate conduct during an inspection, including both the personnel that will […]

Jun

Rescinding Breakthrough Therapy Designation – Guidance Provides FDA’s Thinking

By Bob Pollock Jun 29, 2022 Breakthrough designation FDA NDA Regulatory Affairs

The breakthrough therapy designation (BTD), once awarded to a drug product under development, triggers a rather intensive use of Agency resources, such as providing “early and frequent advice, conduct multidisciplinary meetings involving senior managers, and when appropriate, expedite the review of resultant marketing applications.” The program is designed to “facilitate and expedite” review of promising […]

Jun

REMS for New OTC Conditions of Use – Well, Kind Of!

By Bob Pollock Jun 28, 2022 ANDAs NDA OTC Regulatory Affairs

The FDA has issued a proposed rule (here) to expand certain new conditions of use for OTC products. When an OTC product is approved through an NDA, it should have all of the necessary information in the Drug Facts section of the label so the consumer can properly select whether the product is appropriate for […]

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NDA

FDA Updates Draft Guidance on Required Notification of Discontinuance or Interruption in Manufacturing of Finished Products or Active Pharmaceutical Ingredients Under Section 506C of the FD&C Act

Accelerated Approvals – Here Is One to Watch

OTC Naloxone Coming Down the Road? FDA Would Like to Think So!

Industry and Regulators Working to Prevent Drug Shortages

Convergence and Collaboration Themes at 2022 ISPE Annual

Everything You May Want to Know About Therapeutic Equivalence (and More!)

How to Prepare for an FDA Inspection – Important Things to Know, from the Perspective of a Former Investigator (Part 3)

How to Prepare for an FDA Inspection – Important Things to Know from the Perspective of a Former Investigator (Part 2)

Rescinding Breakthrough Therapy Designation – Guidance Provides FDA’s Thinking

REMS for New OTC Conditions of Use – Well, Kind Of!

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