Enforcement

05
Jul

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

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. […]

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30
Jun

How to Prepare for an FDA Inspection – Important Things to Know from the Perspective of a Former Investigator (Part 1)

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 […]

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08
May
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Even In the Face of COVID 19, the Beat Still Goes On

Although though we are in the grips of a pandemic and our attention is focused on the development of treatments and vaccines for COVID-19, manufacturing of drug products to treat other conditions is continuing, and GMPs must still be maintained. Sponsor companies continue to manufacture products and are still dependent upon products and services from […]

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19
Feb
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Sometimes you get what you pay for; FDA joins forces with India to halt illicit drug sales

The United States Food and Drug Administration and the Indian Government join forces in “Operation Broadsword”.  No, it’s not a trailer for an action thriller, it’s a serious collaboration between two governmental entities to limit the import and sale of illicit drugs to consumers, detailed in FDA’s news release on February 18, 2020 (here). The […]

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12
Feb
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Promoting Confidence Through Product Quality – OPQ 2019 Annual Report

   The FDA’s Office of Pharmaceutical Quality (OPQ) is the group within the FDA that defines the quality requirements for all human drugs under its umbrella (filed as NDAs, ANDAs, BLAs, 351(k)/Biosimilars, and OTC products).  The group issued its 2019 Annual Report just this month (read the full report here) that includes a look back […]

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10
Feb
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The Importance of Sampling Plans for Uniformity of Dosage Testing

Numerous health authorities have cited companies for inadequate sampling plans of finished drug products. A recent 483 issued to a finished drug‑product firm specifically mentions the firm’s lack of a scientifically sound statistical sampling plan during production of all strengths of its drug product.  The FDA also mentions that this firm uses content uniformity results […]

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05
Feb
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FDA and FTC Announce a Coordinated Plan for Advancing Competition in the Biologic Drug Marketplace

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 […]

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12
Jul

Understanding the Mutual Recognition Agreement (MRA)

It certainly seems that the world is getting smaller and this concept has been coming to the regulated industry for quite some time now.  As early as 1999, the European Commission has been working diligently with the EMA and other regulatory bodies throughout the world to form Mutual Recognition Agreements (MRAs) related to inspections and […]

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