Compounding Documents; Public Meetings; Guidance Documents;
and Request for Comments
1. Pharmacy Compounding
a. Draft Guidance for Industry - Adverse Event Reporting for Outsourcing Facilities Under Section 503B of the Federal Food, Drug, and Cosmetic Act
Under the Federal Food, Drug, and Cosmetic Act (the FD&C Act), an outsourcing facility must submit adverse event reports to FDA. This guidance explains FDA's current thinking on adverse event reporting for outsourcing facilities.
b. Draft Guidance for Industry - Guidance for Entities Considering Whether To Register as Outsourcing Facilities Under Section 503B of the Federal Food, Drug, and Cosmetic Act
This draft guidance is intended to inform entities that are considering registering as outsourcing facilities under section 503B of the Federal Food, Drug, and Cosmetic Act (the FD&C Act), as added by the Drug Quality and Security Act (DQSA), of the regulatory implications of registration as an outsourcing facility.
c. Memorandum of Understanding Addressing Certain Distributions of Compounded Human Drug Products between the States and the Food and Drug Administration; New Proposed Draft
FDA is announcing the availability for public comment of a draft standard memorandum of understanding (MOU) entitled “Memorandum of Understanding Addressing Certain Distributions of Compounded Human Drug Products between the State of [insert State] and the U.S. Food and Drug Administration.” The draft standard MOU describes the responsibilities of the State that chooses to sign the MOU in investigating and responding to complaints related to compounded human drug products distributed outside the State and in addressing the interstate distribution of inordinate amounts of compounded human drug products.
d. Draft Guidance for Industry - Repackaging of Certain Human Drug Products by Pharmacies and Outsourcing Facilities
This guidance describes the conditions under which FDA does not intend to take action for violations of the Federal Food, Drug, and Cosmetic Act (the FD&C Act), when a state-licensed pharmacy, a Federal facility, or an outsourcing facility repackages human drug products.
2. Public Meetings/Workshops
a. Public Meeting/ Request for Comments - Supplemental Applications Proposing Labeling Changes for Approved Drugs and Biological Products
The purpose of this meeting is to provide a public forum for FDA to listen to comments on the proposed rule on “changes being effected” supplements that was published in the Federal Register of November 13, 2013, and alternatives offered to this proposed rule. FDA is also reopening the comment period for the proposed rule to receive submissions of additional written comments on the proposed rule as well as alternative proposals presented during the public meeting.
The public meeting will be held on March 27, 2015, from 8 am to 5 pm at the FDA White Oak Campus in Silver Spring, MD.
b. Public Workshop- Society of Clinical Research Associates-Food and Drug Administration; “Food and Drug Administration Clinical Trial Requirements, Regulations, Compliance and Good Clinical Practice”
This public workshop is designed to aid the Clinical Research Professional's understanding of the mission, responsibilities and authority of the FDA and to facilitate interaction with FDA representatives. The program will focus on the relationships among the FDA and clinical trial staff, investigators and institutional review boards (IRB). Individual FDA representatives will discuss the informed consent process and informed consent documents; regulations relating to drugs, devices and biologics, as well as inspections of clinical investigators, of IRB, and of research sponsors. The conference will be held on March 11 and 12, (Wednesday and Thursday) 2015, from 8:00 am to 5 pm in San Francisco, CA.
3. Other Guidance Documents
a. Draft Guidance for Industry - Alcoholism: Developing Drugs for Treatment
The purpose of this guidance is to assist sponsors in the development of drugs for the treatment of alcoholism.We are issuing this guidance to better communicate our current thinking on the appropriate endpoints for clinical trials of drugs to treat alcoholism, and to apprise sponsors of possible alternatives to abstinence-based endpoints, which have often been considered an unattainable threshold in the clinical trial setting, and which may be considered a hindrance to clinical development for drugs to treat alcoholism.
b. Guidance for Industry - Complicated Urinary Tract Infections: Developing Drugs for Treatment
The purpose of this guidance is to assist sponsors in the clinical development of drugs for the treatment of complicated urinary tract infections (cUTIs). This guidance finalizes the revised draft guidance of the same name issued on February 24, 2012.
4. Request for Comments: Identifying Potential Biomarkers for Qualification and Describing Contexts of Use to Address Areas Important to Drug Development
FDA is seeking information to facilitate development and qualification of biomarkers in areas related to human drug therapeutics. Towards this goal, FDA is encouraging interested groups and individuals to submit information on specific medical and biological areas where novel biomarkers can be identified that would meaningfully advance drug development. FDA encourages respondents to describe evidentiary considerations that are important to qualify these biomarkers for a specific context of use. Details of information that should be provided to the Agency are described in the survey.
The Small Business and Industry Assistance program in the Center for Drug Evaluation and Research (CDER SBIA) provides guidance and information to regulated domestic and international small pharmaceutical business and industry through its website, email notifications, and workshops. This notification system provides current information from CDER/FDA via e-mail on a biweekly basis that is relevant to small pharmaceutical business, which includes Federal Register notices, guidances, workshop announcements, etc. This is an automated message delivery system. Replying to this message will not reach the CDER SBIA staff. If you have comments or questions, please contact us Monday through Friday 8:00AM - 4:30PM.
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