May 2018

31
May
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Q12 Technical and Regulatory Considerations for Pharmaceutical Product Lifecycle Management Issued by the FDA

This formal ICH Guidance document (here) describes the entire post-approval lifecycle management of changes that are to be made after initial approval of a regulatory submission. The document is quite comprehensive but, as always, because of inherent differences in the various regulatory authorities, there are limitations to its universal application.  As the guidance document notes, […]

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30
May
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Got Life? – Check Out the Analytical Procedure Lifecycle

During 2017, the USP issued a Stimuli article for a proposed new chapter, titled “The Analytical Procedure Lifecyle <1220>”, which incorporates the concept of Quality By Design (QbD) and the principles of ICH Q8-R2, Q9, and Q10 for the development and management of analytical test procedures. There are three lifecycle phases: Procedure Design and Development […]

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29
May
Female chemist at work in laboratory.

Is the FDA Telling You Something?  Final Bioanalytical Guidance May Point the Way!

Earlier last week, the U.S. FDA released its final guidance document, “Bioanalytical Method Validation.”  This is great news as the bioanalytical industry has been waiting for the draft guidance (issued September 2013) to be finalized.  For all bioanalytical laboratories that were following the previously issued final guidance, “Bioanalytical Method Validation” issued in May 2001, or the […]

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24
May

FDA Warns of Potential Fatal Adverse Events with the Use of Benzocaine

The FDA is urging manufacturers to stop marketing oral OTC benzocaine products for teething and infants and children younger than 2 years of age.  FDA also warns this is not just a problem with younger age groups.  The product (which is both available for teething and oral spray product for adults) can trigger methemoglobinemia shortly […]

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23
May
Young mother applying suntan lotion on daughter's face at the beach

Let the Sun Shine on OTC Sun Screen Products

The FDA has revised and finalized its previously issued (2011) Enforcement Policy OTC Sunscreen Drug Products Marketed Without an Approved Application Guidance for Industry.  FDA notes that “this guidance applies to OTC sunscreen products marketed without approved applications and describes FDA’s approach to enforcement for these products until a final OTC sunscreen monograph becomes effective.”  […]

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21
May

MHRA, March 2018 ‘GXP’ Data Integrity Guidance and Definitions

Since the 1938 United States Food, Drug and Cosmetics Act was put in place, legal requirements have existed mandating the integrity of the manufacturing and laboratory data supporting product quality and ensuring patient safety.  However, only within the last 10 years has the topic of data integrity been widely discussed and numerous guidance documents (draft […]

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17
May
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Will Public Shaming Stop the Gaming of the System?

Today, the FDA published a list of innovator companies for which FDA has received requests from generic sponsors to request that the Agency intercede in obtaining samples so the generic applicant can conduct the necessary bioequivalence (BE) testing to support ANDA approval.  The FDA has taken this extraordinary approach to provide greater transparency regarding this […]

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