The FDA’s newly updated guidance agenda for 2016 provides a glimpse into the areas the Agency plans to focus on over the next few months. With 102 total guidances currently on the list, this year will see a modest increase in new regulatory initiatives compared to last year’s total of 92.
A look at the list reveals three areas of interest that stick out among the rest:
- Pharmaceutical quality manufacturing standards
- Pharmaceutical quality/CMC
- Generics
While the full list of the proposed guidances is available here, we’ve summarized the three key points of focus along with some additional insights into these topics below.
Pharmaceutical quality manufacturing standards
There are currently three planned guidances that will focus on the standards for quality manufacturing:
• CGMP Data Integrity Questions and Answers
• Expiration Dating of Unit-Dose Repackaged Solid Oral Dosage Form Drug Products
• Repackaging of Certain Drug Products by Pharmacies and Outsourcing Facilities
If prior CGMP guidances are any indication of what to expect in the future, it appears the FDA will soon answer many of the common questions concerning data integrity just as they did in their previous Records and Reports guidance. In addition, we can also expect to see clarification on expiration dating for repackaged drug products—a regulatory area that hasn’t seen new compliance guidelines since 2005.
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Pharmaceutical quality/CMC
Also notable is the number of guidances planned to address the quality of pharmaceutical products themselves. Right now, the FDA plans to publish 16 guidances throughout the year, covering topics like:
• Assay development and validation for therapeutic proteins
• Comparability protocols for approved drugs
• In vitro evaluation of opioids for abuse deterrence
• Chemistry, manufacturing and controls documentation for inhalers
• Quality metrics conformance
• Regulatory classification of pharmaceutical co-crystals
• Specified synthetic biological products
• Using FDA inactive ingredient software (IIDs)
• Quality considerations for chewable tablets
As mentioned in a recent FDA blog post, 65 percent of all drug shortages have been shown to be a result of manufacturing and quality issues. According to Dr. Michael Kopcha, Ph.D., R.Ph., the FDA will take steps to help companies pursue new technologies to overcome these challenges while creating a more robust drug manufacturing process to minimize interruptions.
In particular, 2016 will see the rise of the FDA’s Emerging Technology Team (ETT)—a group of industry specialists that will work directly with manufacturers to identify and resolve scientific issues for innovative technologies.
The FDA’s recent guidance, Advancement of Emerging Technology Applications to Modernize the Pharmaceutical Manufacturing Base clarifies exactly how the agency plans to use the ETT to help advance new products.
Generics
As mentioned by CDER director Janet Woodcock this past January in an address to congressional leaders, the FDA is making significant progress in reducing the backlog of abbreviated new drug applications for generics, expecting to be fully caught up by the time the Generic Drug User Fee Act is renewed in 2017.
This year’s list of forthcoming guidances reinforces that commitment with the introduction of twelve initiatives focused on generics specifically. Topics include:
• 180 Day Exclusivity
• Content and formatting for abbreviated ANDAs
• Assessing Adhesion for ANDAs
• Bioequivalence studies for submitted drug products
• When to submit an application under 505(b)(2) or 505(j)
• Updating ANDA labeling after withdrawing the marketing application
• Evaluating abuse-deterrent properties of generic solid oral opioid drug products
As it mentioned in the listing notice, the agency will likely not complete all of the items listed and will rely on input from stakeholders to prioritize how resources are allocated.
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The FDA is inviting “interested persons to submit comments on any or all of the guidance documents on the three lists,” including suggestions for other topics that should be addressed in future guidance documents. Comments can be submitted electronically through www.regulations.gov.
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