01
Jul

Continuous Manufacturing vs. Batch Manufacturing – Where Will the Industry Go?

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 […]

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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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21
Jun

Official Approval Numbers for May 2022 and Update on April Stats

Well, just like that, OGD posted the official approval actions along with some other metrics for May and also updated the rest of the April statistics.  We have been touting the May approval action and we were ever-so-close but missed by one. The actual official May approval actions are as follows: Full approval actions 84 […]

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16
Jun
Pattern obtained by superimposing black numbers on multicolored background. This is obtained by multiple colors paint watercolor technique on paper.

A Peek at Mid-Month June 2022 Approval Actions

June looks fairly strong but likely not as strong as May’s projected unofficial total (ninety‑three full and tentative actions).  With postings through June 14th on the FDA’s Daily and All Approval lists (here and here), as of 10:30 a.m. on June 16, 2022, there were twenty‑three full‑approval actions and nine tentative‑approval actions.  This total of […]

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06
Jun

April Showers Did Bring May Flowers! A Look at the May Unofficial Approvals

The “rain” of approval actions in April led to an unofficial “sprouting” of 83 full approvals in May, which was the largest number of full approvals seen in quite some time; specifically, since May 2019 when there were also 83 full approvals.  While not an all-time high for a single month, it is a welcome […]

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20
May

More PSGs Issued by OGD

Yesterday, the Office of Generic Drugs released twenty-four new and thirteen revised Product Specific Guidances (PSGs) with recommendations for conducting studies necessary to establish bioequivalence between test and reference products.  Of course, the revisions might spell trouble for applicants that have already commenced testing according to the original guidances, but this has been a bone […]

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16
May

The Significance of Data Invalidation

When reviewing health agency citations, investigators are naturally concerned when observing cases of data invalidation during investigations and may well question the motives/justification accordingly. This can lead to some uncomfortable exchanges between firms and health agencies! So how should a laboratory protect themselves from such a situation? First, you want to ensure that, per your […]

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11
May

The Battle of Harmonization Continues! It Takes Time – Day 2

Tuesday’s session of the Fiscal Year (FY) 2022 Generic Drug Science and Research Initiatives Public Workshop opened with a presentation by Michael Banks, Senior Vice President, Global Head Regulatory Affairs, Teva Pharmaceuticals discussing the global challenges to the development of complex generic drugs.  Dr. Banks challenged the regulatory bodies to move towards more standardized approaches […]

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28
Apr

The Future of Us

As our world spins toward the highly anticipated “new normal,” pharma and related industry conferences in the last few months have shown us that the new normal will be anything but business as usual.  Instead, we are witnessing an accelerated adoption of advanced new technologies that many of us had previously associated with the IT […]

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