The Small Biz Buzz
The Information Source for Regulated Domestic and International Small Pharmaceutical Business
FDA is announcing a public hearing to obtain input on a new paradigm we are considering. Under this paradigm, the Agency would approve certain drugs that would otherwise require a prescription for nonprescription use (also known as over-the-counter or OTC) under conditions of safe use. These conditions of safe use would be specific to the drug product and might require sale in certain pre-defined healthcare settings, such as a pharmacy. This public hearing is being held to obtain information and comments from the public on the feasibility of this paradigm and its potential benefits and costs. Date: March 22-23, 2012 Time: 9:00 a.m. to 4:00 p.m. Location: FDA White Oak Campus Please find additional information at: http://www.fda.gov/Drugs/NewsEvents/ucm289290.htm Federal Register Notice: http://www.ofr.gov/OFRUpload/OFRData/2012-04597_PI.pdf 2. Food and Drug Administration Clinical Trial Requirements, Regulations, Compliance, and Good Clinical Practice FDA Detroit District Office, in co-sponsorship with the Society of Clinical Research Associates (SoCRA) is announcing a public workshop. The public workshop on FDA’s clinical trial requirements is designed to aid the clinical research professional’s understanding of the mission, responsibilities, and authority of FDA and to facilitate interaction with FDA representatives. The program will focus on the relationships among 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, IRB, and research sponsors. Date and Time: The public workshop will be held on May 9 and 10, 2012, from 8 a.m. to 5 p.m. Federal Register Notice: http://www.gpo.gov/fdsys/pkg/FR-2012-02-15/pdf/2012-3553.pdf 3. Draft Guidance on Investigational New Drug Applications for Positron Emission Tomography Drugs FDA is announcing the availability of a draft guidance entitled ‘‘Investigational New Drug Applications for Positron Emission Tomography (PET) Drugs.’’ The draft guidance is intended to assist manufacturers of PET drugs in submitting investigational new drug applications (INDs). Federal Register Notice: http://www.gpo.gov/fdsys/pkg/FR-2012-02-14/pdf/2012-3319.pdf 4. Final Recommendation for the Revision of the Permitted Daily Exposure for the Solvent Cumene According to the Maintenance Procedures for the Guidance Q3C Impurities: Residual Solvents FDA is announcing the availability of a final recommendation for the revision of the permitted daily exposure (PDE) for the solvent cumene according to the maintenance procedures for the guidance for industry entitled ‘‘Q3C Impurities: Residual Solvents.’’ Federal Register Notice: http://www.gpo.gov/fdsys/pkg/FR-2012-02-23/pdf/2012-4164.pdf 1. Utilizing Innovative Technologies and Other Conditions of Safe Use To Expand Access to Nonprescription Drugs
10903 New Hampshire Avenue
Bldg. 31, Room 1503
Silver Spring, Maryland 20993
The Small Business Assistance (SBA) program in the Center for Drug Evaluation and Research (CDER) provides guidance and information to regulated domestic and international small pharmaceutical business 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 SBA staff. If you have comments or questions, please contact us Monday through Friday 8:00AM – 4:30PM. Please take our CDER Small Business survey: https://www.surveymonkey.com/s/cdersmallbusiness
| This email was sent to clotito+biotechdash@gmail.com using GovDelivery, on behalf of: U.S. Food & Drug Administration (FDA) · 10903 New Hampshire Ave · Silver Spring, MD 20993 · 800-439-1420 |  |
No comments:
Post a Comment