Science & Technology

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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10
May

Lots of Questions and Lots of Industry Advice in Research Initiatives Workshop Day 1

The FY 2022 Generic Drug Science and Research Initiatives Public Workshop held May 9-10, 2022, addressed a significant number of complex drug product questions as well as feedback from the industry as to what steps would be helpful for FDA to undertake to facilitate complex product development, review, and approval.  With GDUFA III considered to […]

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06
May

Hold On! That Previously Acceptable Level of Nitrosamine in Your Product is No Longer Acceptable!

Yesterday, the Agency expressed confidence that manufacturers of varenicline tablets containing the N‑nitroso-varenicline impurity can meet the FDA’s original acceptable intake limit of 37 ng or less per day. Their statement read:  “FDA is now confident in manufacturers’ ability to supply patients with varenicline containing the N-nitroso-varenicline impurity at or below the agency’s acceptable intake limit […]

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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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19
Apr
Continuous Manufacturing and its Regulatory Challenge Image

Particles, Particles, Particles – Some Have a Game Plan

During day 2 of the PDA conference, there was a very enlightening session called “Game Plan: Progress to the Next Stage of Contamination Control.”  Anne Marie Dixon-Heathman, President of Cleanroom Management Associates, Inc., gave a presentation called “Contamination Control: A new approach to the Reduction of 5-micron particles.”  She discussed product loss resulting from five-micron […]

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15
Apr

MaPP Out – What Constitutes a Complex Generic Drug? FDA Explains

On April 15, 2022, FDA published a Manual of Policy and Procedures (MaPP) that outlines the FDA thinking on what constitutes a complex drug product for purposes of classification.  A MaPP, as you know, is not an industry tool, but rather an instruction to FDA staff as to the policy and procedure that they  utilize […]

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06
Apr
Hand Holding a Chemical Solution Test-tube in a bio-Chemistry DNA Research Laboratory

ICH Q14: Analytical Procedure Development and Revision of Q2(R2) Analytical Validation

The ICH has developed a draft of the new ICH Quality Guideline, ICH Q14, Analytical Procedure Development, and revision of ICH Q2(R2), Guideline on Validation of Analytical Procedures, both endorsed on March 22, 2022 for public consultation.  The draft, along with other ICH guidances on validation and analytical procedures, can be found here. The draft revision of […]

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06
Apr

Some Interesting Takeaways from PDA Meeting Day 1

The theme for the PDA annual meeting this year is “Agility in the New Normal.”  The plenary address kicked off the meeting with an interesting presentation by Dr. Jeffrey Baker, Senior Fellow, National Institute for Innovation in Manufacturing Biopharmaceuticals (NIIMBL), titled “Pandemic Response, Regulatory Rubric, and the Nature of Rubber Bands.”  He spoke about the intrinsic […]

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