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OGD Perspectives Gary J. Buehler, R.Ph. Director, Office of Generic Drugs October 26, 2005 GPhA Fall Technical Conference.

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Presentation on theme: "OGD Perspectives Gary J. Buehler, R.Ph. Director, Office of Generic Drugs October 26, 2005 GPhA Fall Technical Conference."— Presentation transcript:

1 OGD Perspectives Gary J. Buehler, R.Ph. Director, Office of Generic Drugs October 26, 2005 GPhA Fall Technical Conference

2 FDA/GPhA Fall Technical Conference2 Topics Productivity Operations Issues New Endeavors Positive Progress Industry Contribution

3 FDA/GPhA Fall Technical Conference3

4 4

5 5

6 6 Office of Generic Drugs

7 FDA/GPhA Fall Technical Conference7 Operations Issues

8 FDA/GPhA Fall Technical Conference8 Hiring IO37 - Chem I Chem II26 +1 Chem III BioEquiv LPS50 +2 TOTAL201 9 On Board Change (over FY) Oct 2005

9 FDA/GPhA Fall Technical Conference9 Hiring Process Delays Often takes 6 months or more, from initial contact, to complete the hiring process Has been difficult to hire enough additional reviewers to address the increase in submissions We continue to fall behind – especially in Division of Bioequivalence and Microbiology staffs

10 FDA/GPhA Fall Technical Conference10 Immediate Office Move 7519 Standish 7500 Standish

11 FDA/GPhA Fall Technical Conference11 Staff Affected by Move Gary Buehler Pat Downs Sam Haidar Don Hare Rita Hassall Hyojong Kwon Melissa Lamb LaiMing Lee Sau Lee Robert Lionberger Patti Littleton Cecelia Parise Genie Patrick Andre Raw Dave Read Ruth Warzala Kristin West Lawrence Yu to 7519 Standish Place

12 FDA/GPhA Fall Technical Conference12 CDER Offices at White Oak Office of Pharmaceutical Science (except OGD) Office of Counter Terrorism and Pediatric Drug Development Office of Clinical Pharmacology and Biopharmaceutics Office of New Drugs Office of Medical Policy (including DDMAC) Office Pharmacoepidemiology and Statistical Science

13 FDA/GPhA Fall Technical Conference13 CDER Offices at White Oak Effect on OGD More difficult to communicate with OND and OPS directly More time devoted to travel between FDA buildings We believe it is critical to maintain face-to-face contact with these and other offices in CDER

14 FDA/GPhA Fall Technical Conference14 Review Issues Overall review workload as noted PEPFAR Petitions – actively working on 14 Emphasis on safety concerns, e.g., isotretinoin; transdermals

15 FDA/GPhA Fall Technical Conference15 New Endeavors – IO Perspective Structured Product Labeling (SPL) Makes labeling available on Internet via National Library of Medicine (NLM) Review Efficiencies Early DMF review Cluster reviews – product specialists Supplement triaging at team leader level DBE Truncated Review Question based Review (QbR) Will have a very positive impact

16 FDA/GPhA Fall Technical Conference16 On a Positive Note... New resources developed Dissolution Database Individual Product Bioequivalence Information Encouraged the use of telephone in review process Increased the number of 1 st cycle approvals Decreased the total number of review cycles Total time to approval did not increase in spite of increased workload

17 FDA/GPhA Fall Technical Conference17 Dissolution Methods for Drug Products New!!

18 FDA/GPhA Fall Technical Conference18 ben

19 FDA/GPhA Fall Technical Conference19

20 FDA/GPhA Fall Technical Conference20 This guidance contains an Internet link to a listing of drug products, each linked in turn to a corresponding bioequivalence recommendation. Clicking on a product name in that list will bring up the bioequivalence recommendations for that specific product. Recommendations have been developed for several drugs that are not yet eligible for generic competition (i.e., newly approved products) and some older products for which information has previously been provided. As additional recommendations are developed, those will be posted on the Web site. When this guidance is finalized, the listing will be available through the Agencys Web page.

21 FDA/GPhA Fall Technical Conference21 OFFICE OF GENERIC DRUGS TABLE OF BIOEQUIVALENCE RECOMMENDATIONS Active IngredientPotency Dosage Form Route of AdministrationDate Finalized Almotriptan Malate 12.5 mgTabletOral5/16/2005 Alosetron 1 mgTabletOral5/31/2005 Atazanavir 200 mgCapsuleOral3/18/2005 Atomoxetine 60 mgCapsuleOral6/13/2005 Cefditoren Pivoxil 200 mgTabletOral3/18/2005 Dutasteride 0.5 mgCapsuleOral7/5/2005 Eplerenone 50 mgTabletOral3/18/2005 Fosamprenavir Calcium 700 mgTabletOral3/18/2005 Memantine 10 mgTabletOral7/8/2005 Rosuvastatin 40 mgTabletOral3/18/2005 Tadalafil 20 mgTabletOral3/18/2005 Vardenafil HCl 20 mgTabletOral4/11/2005

22 FDA/GPhA Fall Technical Conference22 Industry Contribution

23 FDA/GPhA Fall Technical Conference23 You Can Help Participate in the new initiatives Respond quickly Utilize available online resources Submit applications electronically Provide feedback on OGD processes

24 FDA/GPhA Fall Technical Conference24 You Can Help - Microbiology Changes to Container/Closure System Glass Vials (e.g., change from Type II to Type I, or vial vendor change) a) Identical vial opening dimensions: no C/C integrity validation needed, b) Non-identical opening dimensions: perform C/C integrity validation Stoppers (change in rubber formulation): Perform C/C integrity validation

25 FDA/GPhA Fall Technical Conference25 You Can Help - Microbiology General Supplement Info: Note (in cover letter) ANDA/NDA/Supplement numbers in which the change was previously submitted/approved Note (in cover letter) whether the newly submitted information is identical to or represents updated information contained in the initial supplement

26 FDA/GPhA Fall Technical Conference26 You Can Help - Microbiology General Supplement Info – continued: For minor (Micro Only) changes affecting multiple applications, OGD Micro is amenable to a single initial supplement filing followed by AR filing for subsequent reporting of the same change, provided all affected applications or products are delineated in the initial supplement. Otherwise, products not listed in the initial supplement would require CBE-30/0 supplement

27 FDA/GPhA Fall Technical Conference27 Emphasis on safety Maintaining integrity of generic drug review A Final Word

28 FDA/GPhA Fall Technical Conference28 Center for Drug Evaluation and Research Office of Generic Drugs HFD Standish Place Rockville, MD


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