jueves, 10 de abril de 2014

CDER SBIA Update: New Meetings, Announcements, Dockets, and Guidances

The Small Biz Buzz
The Information Source for Regulated Domestic and International Small Pharmaceutical Business and Industry
FDA/CDER's Small Business and Industry Assistance (CDER SBIA)

1. FY 2014 GDUFA Regulatory Science Funding Announcements
As part of the Generic Drug User Fee Amendments (GDUFA) of 2012, the FDA held a public meeting on June 21, 2013 to seek input from a variety of stakeholders in developing the FY 2014 Regulatory Science Initiatives.
The resulting FY 2014 research priorities are: post-market evaluation of generic drugs, equivalence of complex products, equivalence of locally-acting products, therapeutic equivalence evaluation and standards, and computational and analytical tools. Scientific research opportunities funded through the GDUFA Regulatory Science Research Program are announced on Grants.gov and FedBizOpps.gov.
The grant announcement (and contracts when they are announced) are now posted on our website (under Opportunities for Collaboration).  As we announce more grants (and contracts), they will be included in this new webpage.  The link for each announcement will be inactivated once the announcement period closes. You may refer directly to the following webpage:http://www.fda.gov/ForIndustry/UserFees/GenericDrugUserFees/ucm391696.htm
2. FY 2014 Regulatory Science Initiatives Part 15 Public Meeting
On May 16, 2014, will hold a public meeting that provides an overview of the current status of the regulatory science initiatives for generic drugs and there will be an opportunity for public input on research priorities in this area. FDA is seeking this input from a variety of stakeholders––industry, academia, patient advocates, professional societies, and other interested stakeholders––as it fulfills its statutory requirement under GDUFA to develop an annual list of regulatory science initiatives specific to generic drugs.  FDA will take the information it obtains from the public meeting into account in developing the FY 2015 Regulatory Science Plan.
3. FDA opens new public docket to address opioid abuse and misuse through innovative packaging, storage, disposal
FDA is committed to the fight against opioid misuse and abuse, and we would like to direct your attention to a new public docket open for comments. As part of a multi-pronged approach to resolving this issue while maintaining patient access to necessary medication, we are calling on industry, healthcare providers and patient advocacy groups to take an active role in the regulatory process as we determine the next steps for the Agency. 
The public docket, titled: Use of Innovative Packaging, Storage, and/or Disposal Systems to Address the Misuse and Abuse of Opioid Analgesics, published on April 9, 2014, opens a pathway to present to the FDA new ways to combat this growing problem.  Some technologies have already been used for management and monitoring of protocol compliance in clinical trials, and we believe at least some of these technologies can be feasibly adapted to become real-world abuse-deterrent applications. 
For example, new systems may remind patients to take a dose, track when a dose is taken and how much is taken, and limit further access until it is time for the next dose.  New disposal designs can also be adapted, including in-home chemical deactivation, so unused medicine cannot be shared or sold. 
These are just a few examples of the many ways technology and innovation can be incorporated so the FDA can help healthcare providers ensure their patients have access to critical medication while assisting law enforcement by keeping prescription drugs from falling into the wrong hands.
Please visit and comment on our public docket, which is open for comment for 60 days from the date of publication.
For more information, please contact CDERSBIA@fda.hhs.gov

4. Guidance for Industry on Fees for Human Drug Compounding Outsourcing Facilities Under the Federal Food, Drug, and Cosmetic Act 
This guidance is intended for entities that compound human drugs and elect to register as outsourcing facilities (outsourcing facility) under section 503B of the Federal Food, Drug, and Cosmetic Act (FD&C Act), as added by the Drug Quality and Security Act (DQSA). Entities that elect to register as outsourcing facilities must pay certain fees to be considered outsourcing facilities. This guidance describes the annual establishment fee, the reinspection fee, annual adjustments to fees required by law, how to submit payment, the effect of failure to pay fees, and how to qualify as a small business to obtain a reduction of the annual establishment fee.

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