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Author Archives: Mark Cierpial

Modification versus Revision: It Matters a Great Deal When it Comes to Your REMS

April 30, 2015 | Mark A. Cierpial, PhD, RAC, Chief Executive Officer | Regulatory Affairs

Modification – “The act or process of changing parts of something” According to a recent guidance issued by the FDA, modifications and revisions are not the same thing when it comes to changes to approved Risk Evaluation and Mitigation Strategies.

Need to update your REMS? Read on!

Revision – “A change or set of changes that corrects or improves something”

What are REMS?
Risk Evaluation and Mitigation Strategies, or REMS, are risk management plans which FDA sometimes requires for certain marketed products to ensure that their benefits outweigh their risks.

Standard risk management techniques for all products include describing the risks and benefits of the product in its labeling and performing required safety reporting.

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FDA Introduces “New” Formal Meeting Format

April 9, 2015 | Mark A. Cierpial, PhD, RAC, Chief Executive Officer | Regulatory Operations, Drug Development Consulting

We previously blogged (here) on the FDA’s release of a draft guidance document that revises their 2009 guidance on formal meetings with sponsors and applicants. One of the significant changes being made is the addition of a new meeting format option – a so-called “written responses only” meeting.

    Have you seen this header already on FDA meeting correspondence?

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Pregnancy and Lactation Labeling Gets a Face Lift

March 17, 2015 | Mark A. Cierpial, PhD, RAC, Chief Executive Officer | Regulatory Affairs

Since implementation of the Physician Labeling Rule (PLR) back in 2006, the FDA has been working to improve the content and format of prescription drug labeling. The most recent improvement comes with the issuing of a final rule, as well as a draft guidance document, on pregnancy and lactation labeling.

If you are planning an NDA or BLA submission, or have one currently under review, you need to be aware of these changes!

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FDA Senior Official’s Top 10 Changes for CDER in 2015

March 12, 2015 | Mark A. Cierpial, PhD, RAC, Chief Executive Officer | Regulatory Affairs

cedResearch Triangle Park’s Council for Entrepreneurial Development (CED), in collaboration with the NC Biotechnology Center and the NC Biosciences Organization (NCBIO), held its annual Life Sciences Conference last week with the theme of #TheNext10.

The Triangle’s premier entrepreneurial event, which brings together life science pioneers, visionaries, and investors to network and share strategies and experiences, was held at the Raleigh Convention Center, March 3-4.

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