Regulatory Intelligence

(Available from Internet, E-mail and other Automatic means)

Advisory Committee Meetings - Additional information can be obtained from the FDA Advisory Committee Hotline at 1-800-741-8138 (301-443-0572 in the Washington area). Other information available via e-mail is available from the following:

• To obtain a complete list of documents available by bounce-back e-mail, send an e-mail to:DOC_LIST@A1.CBER.FDA.GOV 
  

• To request specific documents, send an e-mail to: [document name]@A1.CBER.FDA.GOV 
  

• CDER New Website Information - To receive a daily e-mail notification of new material on CDER's website, send a subscription message to fdalists@www.fda.gov.In the message body enter: subscribe cdernew youremailaddress@yourdomain. 

• Certification - The Generic Drug Enforcement Act also amended the Federal Food, Drug, and Cosmetic Act (section 306(k)) to require applicants for drug product approval of human, animal, and biological products to certify that they did not and will not use the services of a debarred individual or firm in any capacity in connection with the application. Section 306(k) further requires that applicants for approval of certain generic drugs provide information concerning criminal convictions of individuals and firms involved in the applications.

• Citizens Petition

• Commenting on Proposed Regulations

• Debarment - The Generic Drug Enforcement Act, signed into law on May 13, 1992, amended the Federal Food, Drug, and Cosmetic Act (sections 306-308) to authorize FDA to debar an individual, convicted of certain crimes or found to have engaged in certain types of conduct, from providing any services to a drug product applicant. The law also authorizes FDA to debar a firm convicted of certain crimes from obtaining or participating in certain subsequent drug approvals. This debarment extends to persons working for applicants of human, animal, and biological drug products. Any individual found guilty of committing one of the prohibited acts specified in section 307 may be fined up to $250,000. Any corporation, partnership, or association found guilty of committing one of the prohibited acts may be fined up to $1,000,000

• Initiating

• Terminating

Discussion Groups - OnLine groups under the aegis of PharmWeb

• Controlled Release
• Pharmaceutical science-Technology
• Regulatory Affairs

• EUDRA/EMEA now offers a subscription option to receive internet notification of new information.
  

• FAX-on-Demand - CDER's FDA Drug Information Branch. Additional guidances, guidelines, letters to industry, etc., are available through CDER's FAX-on-Demand (FOD) Service at 800-342-2722 or 301-827-0577.

• Federal Register - Comments (see comment above)

• Finding of No Significant Impact (FONSI) - an example of a FONSI issued by the FDA after review of an Environmental Assessment.

• Freedom of Information - Requesting Information

• HUMAN DRUG CGMP NOTES , a periodic memo on Current Good Manufacturing Practice Issues on Human Use Pharmaceuticals, issued by the Division of Manufacturing and Product Quality, HFD-320, Office of Compliance, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, 7520 Standish Place, Rockville, MD 20855.

• Patent Term Extension - an example of the type of document issued by the FDA to extend the term of a patent based on that portion of the review peeriod which is eligible for consideration for extension.

• Recalls - Information about recalls can be obtained from FDA via e-mail. Send an e-mail to FDALISTS@www.fda.gov@pmdf with the message containing "subscribe FRECAL:L" along with your e-mail address.

• Regulatory Letters - Letters from the FDA to applicants/sponsors for site insepctions and labeling/promotional issues.

• Review of Applications - FDA reviews with applicant confidential data removed

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