Office of Generic Drugs: 
Previous News, Announcements and Federal Register Notices

News and Announcements

• Effective 1 Oct, 2003, the Office of Regulatory Affairs (ORA) issued the required notification on Dockets (92S-0251) that ORA is able to access electronic CMC submissions through CDER's Electronic Document Room. This includes both NDAs and ANDAs. Sponsors submitting electronic submissions to CDER do not need to submit an e-submission or paper submission to the ORA District office. ORA requests that the sponsor submit a letter to their home district certifying that the electronic CMC sections has been submitted to CDER.
  Dockets announcement  
• Suggestions for Improving "Controlled Correspondence" to the Office of Generic Drugs.   (Posted 8/27/2003)
• Shared Exclusivity for Paroxetine Hydrochloride Tablets [HTML] or [Word]   (Posted 8/4/2003)
• On June 26, 2003, a Generic Pharmaceutical Association/Office of Generic Drugs joint meeting was held as a collaborative effort directed at improving the Generic Drug Approval Process.  Meeting agenda and presentations.
• On June 12, 2003, FDA announced new regulations and review procedures to streamline the process for making safe, effective generic drugs available to consumers. FDA Generic Drugs Final Rule and Initiative Information Page   (Posted 6/23/2003) 
• Proceedings from the Office of Generic Drugs "Clonidine Transdermal Systems Meeting", April 29, 2003.  (Posted 6/13/2003) [WORD] or [PDF]
• Exclusivity Determination for Gabapentin   (Issued 1/28/2003, Posted 1/29/2003)
• Presentation:  The FDA Process for Approving Generic Drugs, Gary J Buehler, R.Ph., Director, Office of Generic Drugs, October 29, 2002.  (Posted 11/7/2002) 
  
• October 15-16, 2002, Generic Pharmaceutical Association 2002 Fall Technical Workshop, Hyatt Regency, Bethesda, MD:  The Generic Pharmaceutical Industry:  Regulatory and Scientific Challenges.  Agenda and registration.  (10/4/2002)
  
• Proceedings from the Symposium on the Hatch-Waxman Act, January 30, 2002, Rockville, MD.  (Posted 6/6/2002) 
  • Generic Pharmaceutical Association (GPhA) Materials for 1/30/2002 Meeting with FDA.
  • Pharmaceutical Research and Manufacturers of America: White Paper on Implementation of the Hatch-Waxman Act by the U.S. Food and Drug Administration
  • Generic Pharmaceutical Association Submission to FDA: Reply
  • Pharmaceutical Research and Manufacturers of America:  Response to Written and Oral Submissions by the Generic Pharmaceutical Association on Implementation of the Hatch-Waxman Act by the U.S. Food and Drug Administration.
    
    
• April 8-12, 2002, Generic Pharmaceutical Association Annual Meeting and Educational Conference -  Presentations.  (Posted 4/15/2002)
  • Update from the Office of Generic Drugs
  • Current Bioequivalence Issues
     
• Shared Exclusivity for Omeprazole.  (Posted 12/14/2001)   

Federal Register Notices

• Agency Information Collection Activities; Comment Request; Guidance for Industry--Changes to an Approved New Drug Application or Abbreviated New Drug Application.  (Posted 12/19/2003) [TXT] [PDF] Comments Due February 17, 2004

• Draft Guidance for Industry on Powder Blends and Finished Dosage Units--Stratified In-Process Dosage Unit Sampling and Assessment; Availability [TXT] [PDF] Comments by March 8, 2004
  • The Draft Guidance [Word] or [PDF]
     
• Requirements for Submission of In Vivo Bioequivalence Data; Proposed Rule.  [TXT] [PDF]. Comments January 27, 2004 (Posted 10/29/2003)
  
  
• Review and Revision of Guidances for Industry on the Development of Generic Drug Products; Development and Use of Food and Drug Administration Guidance Documents; Update and Withdrawal of Guidances. [TXT] [PDF] (Posted 10/27/2003)
  
  
• Draft Guidance for Industry on Providing Regulatory Submissions in Electronic Format--Annual Reports for New Drug Applications and Abbreviated New Drug Applications; Availability [TXT] or [PDF]  (Posted 8/2003)
  • The Draft Guidance [Word] or [PDF]
     
• Applications for FDA Approval to Market a New Drug: Patent Submission and Listing Requirements and Application of 30-Month Stays on Approval of Abbreviated New Drug Applications Certifying That a Patent Claiming a Drug Is Invalid or Will Not Be Infringed. [TXT] [PDF]  Effective August 18, 2003. 
  
  
• International Conference on Harmonisation; Guidance on Electronic Common Technical Document Specification; Availability.  [TXT] [PDF] Comments April 2, 2004. (Posted 4/7/2003) 
  • The Guidance

• Draft Guidance for Industry: Bioavailability and Bioequivalence Studies for Nasal Aerosols and Nasal Sprays for Local Action; Availability   [TXT] [PDF]
  • The Guidance (Issued and Posted 4/2/2003)
    
    
• Guidance for Industry on Food-Effect Bioavailability and Fed Bioequivalence Studies; Availability.  [TXT] [PDF]  (Issued and Posted 1/31/2003)
  • The Guidance
     
• Bioavailability and Bioequivalence Requirements; Abbreviated Applications; Final Rule.  [TXT] [PDF] (Issued and posted 12/19/2002) 
  
  

• Labeling of Diphenhydramine-Containing Drug Products for Over-the-Counter Human Use.  [TXT] [PDF]  (Issued 12/6/2002, Posted 12/9/2002) 
  
  

• Determination That Sodium Tetradecyl Sulfate Injection Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness.  [TXT] [PDF] (Issued and Posted 11/7/2002) 
  
  

• 180-Day Generic Drug Exclusivity for Abbreviated New Drug Applications; Proposed rule; withdrawal.  [TXT] [PDF] (Issued and Posted 11/1/2002) 
  
  

• Guidance for Industry on Labeling Over-the-Counter Human Drug Products--Updating Labeling in Reference Listed Drugs and Abbreviated New Drug Applications; Availability.  [TXT] [PDF].  (Issued 10/18/2002, Posted 10/22/2002). 

  • The Guidance

  • Example Drug Facts Labels

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Date Updated, October 26, 2004

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