OTC Process: Future Changes for Non Prescription Drugs?

By Harley Everett Wilcox, MBA

Recent FDA public hearings in 2012 and 2014 regarding non-prescription drugs suggest the agency is interested in modernizing the over-the-counter drug process. The 2012 docket discusses topics on providing citizens with more options for obtaining prescription drugs including relying on self-diagnosis, new technology, and pharmacies vs. standard physician visits.

The 2014 docket outlines current issues with the OTC monograph system and requests public comments for improvements. There is yet an outcome of these meetings and suggested changes to the OTC process and regulations.  A more in-depth examination of the current processes, weaknesses, and possible changes will be addressed in a future presentation. The discussion will cover the monograph system, types of submissions, and possible OTC changes that may include  new guidelines or updates to current procedures such as the NDA Deviation.

Let me know what you think about the dockets and possible outcomes in the comment section below.

New, earlier E/L requirements for infusion sets?

by Dr Wayland Rushing, Ph.D.

Over the last several months we have had multiple clients come to us after being put on clinical hold for their clinical trials. The formulations are all parenterals, which utilize some kind of infusion set-up (IV bags, infusion pumps, etc). The FDA has requested determination of the extractables and leachables of the contact materials of the infusion sets.

In the past, minimal work was done on these sets and the main issue was compatibility between the drug and the materials (i.e. does the drug adhere/absorb onto the materials). Now the FDA is specifically asking for E&L evaluations of the materials, this includes going beyond the standard USP polymer characterization tests.

I have chatted with a couple of consultants on this and it is new to them as well. This seems to be something rather recent wherein the FDA is actually placing them on clinical hold until the information can be provided. As expected, this is a major concern for the companies being placed on hold, as it can be expensive and puts their development plans into a tailspin until they are able to generate the data.

Unfortunately, generating the data is not a quick and easy fix, but we have a process which seems to be appropriate. We design a study that generates the extractables data and the leachables data on the material in a side-by-side fashion. Allowing for at least a rapid generation of data to correlate to determine if any additional studies are going to be required.

PTM by MRM: Introducing New Methods to Solve Old Problems

PTM by MRM: A More Efficient Way to Find What You're Looking For

In biotherapeutic development, post-translational modifications (PTMs) can be as elusive as the proverbial needle in a haystack. Traditional methods for identifying and quantifying PTMs involve a painstaking, linear process of individual assays performed one after the other. They require multiple sample preparations and precious time, and findings are often found insufficient by regulators. ABC Laboratories is pleased to introduce a better way.

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Biosimilars: They Look the Same... But One is a Real Stinker.

Biosimilars Sometimes Behave Differently. The Key is Knowing When it Matters.

Biosimilars by nature look much like their comparator products, but they sometimes behave quite differently. That's because the two products often originate from different cell lines or expression systems. And no matter how hard you strive for parity in the way they're cultured, minor differences in manufacturing can lead to sticky variations in primary amino acid sequence, glycosylation chemical modifications and protein folding issues. The FDA understands biosimilar products sometimes behave differently than their name-brand counterparts. But, they do expect you to understand why those differences occur, and to demonstrate that they have no clinical significance. That's where ABC Laboratories comes in.

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Agrochemical Product Development: Taking Your Product to New Markets?

Get Post-Registration Support from the Product Development Experts at ABC

These days, it takes roughly 10 years and a development budget with eight zeros to successfully register a new crop protection products. But being first to market is just the beginning. Whether you expand into new territories, seek label expansions or require ongoing environmental monitoring, a trusted development partner is just as important post-registration as it is prior to initial regulatory approval.

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Environmental Assessments: Don't Let Your Environmental Package Be a Regulatory Sticking Point

Seamless E/A Solutions from the Drug Development Experts at ABC

A quality Environmental Assessment (EA) package is a critical component of many new drug product submissions. Not having the right data—or not starting EA investigations soon enough—is an often-underestimated development risk. In fact, these common missteps can lead to lengthy environmental fate or ecotoxicity studies that will delay a drug's approval by up to two years. ABC helps develop drugs and evaluates their environmental impacts. Click here for more.

Cytotoxic Drug Development: Choose Your Partner Well

Choose Your Partner Well - Ask ABC

Although regulatory requirements are fundamentally the same for all investigational drugs, working with cytotoxic materials presents unique challenges. Heightened safety procedures and encumbering personal protective equipment can be a drag on timelines—or worse, lead to procedural or analytical errors that compromise data integrity. It's critical to choose a CRO with cytotoxic expertise, yet the field of competent outsourcing partners is small.

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