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. […]
In a recently released publication on the FDA website entitled, An FDA Self-Audit of Continuous Manufacturing for Drug Products (here) the FDA relayed its experience with some quantified data and some estimates of savings from the use of the continuous manufacturing (CM) vs. batch manufacturing (BM) albeit, from a limited number of applications. Key take […]
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 […]
When an FDA investigator walks into your facility and informs you that they are going to conduct an inspection, a tense moment may arise even at the most cGMP (Current Good Manufacturing Practices) compliant facility. Paging the employees to inform them of the presence of FDA at the facility is a common occurrence so that […]
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 […]
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 […]
The FDA recently published an updated version of the Current List of Off-Patent, Off-Exclusivity Drugs without an Approved Generic (here). The list is broken down into two parts that identify either prescription or over‑the‑counter drugs (that require an ANDA as the subject of approval), and each of these respective lists is broken down into two […]
CONTRACT PHARMA ARTICLE: ICH – Q14 Regulatory Report: Analytical Procedure Development Paul Mason, Ph.D., Senior Director at Lachman Consultant Services, Inc., offers analysis and commentary on the draft of the new ICH Quality Guideline, ICH Q14, Analytical Procedure Development, and revision of ICH Q2(R2), Guideline on Validation of Analytical Procedures. In this informative article, Paul […]
The focus on beta‑lactam antibiotics has primarily concentrated on penicillin and its derivatives because of the issue of severe allergy or anaphylaxis that can occur in individuals with sensitivities to these products. Over the years, as more and more non‑beta‑lactam antibiotics were introduced to the market, there has also been growing concern that these new […]
Join Lachman Consultants at the 27TH Annual Medicines for Europe Conference Fran Zipp Will Present as Part of Keynote June 29th to July 1st, 2022 Dolce Sitges Hotel, Sitges (Barcelona) Fran Zipp Will Present as Part of Keynote We hope to see you at this exceptional industry conference where Frances Zipp, President and CEO of […]
