Featured Pharma Online Editorial
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Cleanroom Gowning Compliant With EU GMP Annex 1: An Overview
12/1/2022
This article focuses on cleanroom gowning as it pertains to aseptic manufacturing of medicinal products and the updates to gowning requirements in the revised EU GMP Annex 1 document published in August 2022.
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1 Year Out, Where Do We Stand On DSCSA Implementation?
11/21/2022
This month kicks off the final year of a decade-long process to enhance overall security of the U.S. prescription drug supply chain under the Drug Supply Chain Security Act. This article looks at this year’s DSCSA implementation efforts, before examining where implementation currently stands and what gaps and challenges remain.
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FDA Releases Guidance On Drug Products Containing Nanomaterials
11/18/2022
In the FDA guidance entitled Drug Products, Including Biological Products, that Contain Nanomaterials, “nanomedicine” refers to a drug product that contains at least one component with a dimension in the size range of approximately 1 nanometer (nm) up to 100 nm. Focus of the guidance is on a risk-based regulatory strategy.
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Frequent Deficiencies In GMP Inspections, Part 1
11/14/2022
It is sometimes astonishing how often pharmas and biotechs "commit" similar or even the same GMP mistakes — in (almost) always the same places. Here are two of the most common pitfalls to avoid: inadequate handling of deviations and inadequate handling of changes.
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India’s New Drugs, Medical Devices, And Cosmetics Draft Bill 2022
11/7/2022
To accommodate changing requirements and encourage the adoption of new technology, India’s Ministry of Health and Family Welfare released a draft bill in July 2022 to replace the existing Drugs and Cosmetics Act 1940. What are the major areas of change and how much of an impact will there be?
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Key Insights From The 2022 PDA/FDA Joint Regulatory Conference
11/3/2022
Key focus of this article is spent on thoughts shared by the FDA speakers, including the importance of a quality infrastructure, sustainable compliance, data integrity, and more.
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FDA Releases Final Guidance On RWD/RWE Submissions For Drugs & Biologics
10/20/2022
The guidance describes the approach sponsors should use to identify if and how real-world data (RWD) and real-world evidence (RWE) are incorporated into their regulatory submissions. The FDA notes that this guidance specifically applies to INDs, NDAs, and BLAs that contain RWD and RWE.
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Tips For Your Virtual Meetings With The FDA
10/7/2022
It seems unlikely that the FDA will return to in-person meetings. This author, an FDA veteran, shares tips for pharma, biotech, and medical device companies on many aspects of your virtual meetings with the FDA: optimal timing of your first meeting, the video/teleconference experience, and more.
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FDA User Fee Programs Reauthorized: FDA’s CBER Is A Clear Winner
10/6/2022
Last minute, squeaky clean! After years of planning, negotiation, and input, the user fee reauthorization bill was passed and signed into law on the very date that the programs were scheduled to sunset. This article sums up the key takeaways, CBER's reorganization with new product-specific offices, and more.
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FDA’s RTOR Program: Draft Guidance & Insights
10/4/2022
First launched in Feb. 2018 by the FDA’s Oncology Center of Excellence, the Real-Time Oncology Review (RTOR) program is intended to streamline the review process for oncology drug applications. This article summarizes the new guidance and reviews the performance of the program thus far.