FDA’s CDER Unveils Plans for 2016 Guidance Documents

The agenda of guidance for next year (FDA) Center for Food and Drug Administration of the United States for research and evaluation of drugs (CDER) reveals many new opinion on generic medicines, the pharmaceutical quality, communications and Another recommendation was the deferred label from 2015, especially in the implementation of the security of supply of drugs chain Act (DSCSA).

The 15 categories of policy documents planned for 2016 ranging from advertising (including a potentially controversial communications on unauthorized use, approved or authorized uncleared, human medicines authorized or compensated, biological products, veterinary drugs and medical devices) to (meta clinic -analysis of randomized controlled trials) Safety (new guidelines on post-marketing for vaccines and biologicals) reports.

The total of 102 guidance documents provided is higher than the expected 90 CDER out slightly in 2015 and considerably more than what was planned for 2014 and 2013.

And it is included in both lists in 2015 and 2016: The same three documents biosimilars orientation (interchangeability, labeling and statistical methods to assess the similarity of the data), one on the Internet, social networking and "promotional labeling, one for pregnant women in clinical trials and the other in multiple endpoints in clinical trials, among others.

As manufacturers of generic drugs, the FDA issued new draft guidance on "general principles for assessing abuse-deterrent properties of generic solid oral opioid drugs", "Three years exclusivity determinations of pharmaceuticals" and "Update ANDA After labeling Marketing Application Reference Drug List has been withdrawn. "

Also included in the list this year are the new plans guidance for different types of treatment, including ulcerative colitis (also included in the list in 2015), revised guidance on products of allergic rhinitis and drugs to treat exocrine pancreatic insufficiency.

On the front of the application of DSCSA, which has already begun, it includes six guidance documents from the FDA, all but one (referred Alert field) that were included in the 2015 list:

The annual reports of prescription medicines and wholesale distributors of third party logistics providers;

• Eligible products for acquired rights;
• Rules for the exchange of information for interoperability Tracing Some human medicines over;
• The product identifier for the rights, finished drugs;
• Verification systems of prescription drugs;
• Exemptions, exceptions and exemptions product tracking; Y
• Presentations Alert field report