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Director, Office of Generic Drugs

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Presentation on theme: "Director, Office of Generic Drugs"— Presentation transcript:

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

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

3 FDA/GPhA Fall Technical Conference

4 FDA/GPhA Fall Technical Conference

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Office of Generic Drugs FDA/GPhA Fall Technical Conference

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Operations Issues FDA/GPhA Fall Technical Conference

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Hiring On Board Change (over FY) IO Chem I Chem II Chem III BioEquiv LPS TOTAL Oct 2005 FDA/GPhA Fall Technical Conference

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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 FDA/GPhA Fall Technical Conference

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Immediate Office Move 7519 Standish 7500 Standish FDA/GPhA Fall Technical Conference

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Staff Affected by Move to 7519 Standish Place 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 FDA/GPhA Fall Technical Conference

12 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 FDA/GPhA Fall Technical Conference

13 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 FDA/GPhA Fall Technical Conference

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

15 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 FDA/GPhA Fall Technical Conference

16 FDA/GPhA Fall Technical Conference
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 1st cycle approvals Decreased the total number of review cycles Total time to approval did not increase in spite of increased workload FDA/GPhA Fall Technical Conference

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

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ben FDA/GPhA Fall Technical Conference

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20 FDA/GPhA Fall Technical Conference
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 Agency’s Web page. FDA/GPhA Fall Technical Conference

21 FDA/GPhA Fall Technical Conference
OFFICE OF GENERIC DRUGS TABLE OF BIOEQUIVALENCE RECOMMENDATIONS Active Ingredient Potency Dosage Form Route of Administration Date Finalized Almotriptan Malate 12.5 mg Tablet Oral 5/16/2005 Alosetron 1 mg 5/31/2005 Atazanavir 200 mg Capsule 3/18/2005 Atomoxetine 60 mg 6/13/2005 Cefditoren Pivoxil Dutasteride 0.5 mg 7/5/2005 Eplerenone 50 mg Fosamprenavir Calcium 700 mg Memantine 10 mg 7/8/2005 Rosuvastatin 40 mg Tadalafil 20 mg Vardenafil HCl 4/11/2005 FDA/GPhA Fall Technical Conference

22 Industry Contribution
FDA/GPhA Fall Technical Conference

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

24 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 FDA/GPhA Fall Technical Conference

25 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 FDA/GPhA Fall Technical Conference

26 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 FDA/GPhA Fall Technical Conference

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

28 Center for Drug Evaluation and Research Office of Generic Drugs
HFD-600 7500 Standish Place Rockville, MD FDA/GPhA Fall Technical Conference


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