jueves, 29 de enero de 2015

CDER SBIA Update: New Forms, Guidances, Notices and Rules

FDA/CDER's Small Business and Industry Assistance (CDER SBIA)

New Forms, Guidances, Notices and Rules
1. FDA Form 2252
FDA has released an updated FDA Form 2252 along with newly created instructions. Updates include:
-          New expiration date
-          Field 9b (Distribution Data)

You may download both the form and instructions at:
Please always check the FDA Forms website for the latest versions of forms for use.

2. Draft Guidance for Industry: Evaluating Drug Effects on the Ability To Operate a Motor Vehicle
The purpose of this guidance is to assist sponsors in the evaluation of the effects of psychoactive drugs on the ability to operate a motor vehicle. Driving is a complex activity involving a wide range of cognitive, perceptual, and motor activities. Reducing the incidence of motor vehicle accidents (MVAs) that occur because of drug-impaired driving is a public health priority. This draft guidance recommends using a systematic effort to identify drugs that increase the risk of MVAs as a critical component of assessing drug risk and designing strategies to reduce this risk.

3. Draft Guidance for Industry and FDA Staff: Current Good Manufacturing Practice Requirements for Combination Products;
This guidance describes and explains the final rule on current good manufacturing practice (CGMP) requirements for combination products, including presenting general considerations for CGMP compliance as well as analysis of hypothetical scenarios.

4. Guidance for Industry: International Conference on Harmonisation; S10 Photosafety Evaluation of Pharmaceuticals
The guidance was prepared under the auspices of the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH). This guidance outlines details on when photosafety testing is warranted and on possible assessment strategies; it should be read in conjunction with the ICH M3(R2) guidance, section XIV(14) Photosafety Testing. The purpose of the guidance is to recommend international standards for photosafety assessment and to harmonize such assessments that support human clinical trials and marketing authorization for pharmaceuticals. This guidance finalizes the draft guidance issued on February 4, 2013.

5. Sunscreen Feedback Letters; Notice of Availability Under the Sunscreen Innovation Act
FDA has announced the availability of letters containing FDA's initial determinations and feedback on safety and effectiveness data submitted to demonstrate that certain active ingredients are generally recognized as safe and effective (GRASE) and not misbranded for use in over-the-counter (OTC) sunscreen drug products (sunscreen feedback letters). We are taking this action under the Sunscreen Innovation Act (SIA).

6. Proposed Rule: Electronic Distribution of Prescribing Information for Human Prescription Drugs, Including Biological Products
FDA is proposing to amend its prescription drug and biological product labeling regulations to require electronic distribution of the prescribing information intended for health care professionals, which is currently distributed in paper form on or within the package from which a prescription drug or biological product is dispensed. FDA is also proposing that prescribing information intended for health care professionals will no longer be permitted to be distributed in paper form with the package from which a prescription drug or biological product is dispensed, except as provided by this regulation. We are proposing these actions to help ensure that the most current prescribing information is publicly accessible for the safe and effective use of human prescription drugs.

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.

Please take our CDER Small Business survey: https://www.surveymonkey.com/s/CDERSBIA_Evaluation

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