How an ANDA Gets Approved

108 Pages·2015·1.23 MB·English

“How an ANDA Gets
Approved”
1
Topics Covered
• Recent events affecting approval

• Overview of the disciplines involved in the
approval process

• Areas for industry assistance
2
Early Challenges
• Implementation of the Informatics Platform (IT)
-
New archival system used to track and process applications
- Went live October 1, 2014

• Reorganization
- Creation of the Office of Pharmaceutical Quality

- Separating several review disciplines from OGD

• Increase in new staff
-
Addition of many new reviewers
- Experienced reviewers involved in training

3
Recent Improvements
• Informatics Platform has been tailored to meet our
needs

• OPQ settled into the reorganization, new
processes in place

• New hires becoming more productive

• Experienced reviewers returning to spending
more time reviewing applications

4
FY15 Trends (ANDA Originals) –
Actions Taken by Month (Totals)
Complete Response (CR), Approval (AP), & Tentative Approval (TA)
CR
AP
TA
Grand
Oct 14 Nov 14 Dec 14 Jan 15 Feb 15 Mar 15 Apr 15 May 15 Jun 15 Jul 15 Aug 15 Sept 15
Total
AP 43 28 29 26 27 19 49 46 58 47 58 61 491
CR 44 76 96 104 109 93 115 97 97 129 95 100 1155
TA 10 7 5 5 14 6 20 13 10 12 6 14 122
Emphasis to Reduce Number of
Review Cycles
• Goal to reduce the time for an ANDA to be
approved

• Need improved applications from the applicant

• Increased number of Information Request
(IR)/Easily Correctable Deficiencies (ECD)
communications

6
FY15 Trends (ANDA Originals) –
Actions Taken by Month (Totals)
ECD/IR
ECD/IR
(Data as of 9/21/2015)
+ +
54 493 2,115
2,662
FDA
Pending Filed –No =

Filing Review At Least One Review
Snapshot
with
Review Comm. Communication Issued
FDA

T
C
e
o 3 n
m t
0 a
Monthly ple 83 6 tiv
Average te Re ents Info e Ap +
s m Req. p
p r
(May - August) onse mend 54 ovals
9 A 8 1
9
0

872 276
1,148
Industry Pending + Tentative =

Industry Response to Approval
Snapshot
with
the Complete with
Industry
Response Industry
Current ANDA Workload of
3,810
Original Applications
Refuse to
Total Pre-Y3 1,293 398
Receive
+ + + =
Application Cohort Approva 78 Withdrawal 3,810 5,707
Resubmitted in Y3
ls s
(As of 10/1/2012) 128
No
(from Cohort)
Resubmission
FILING STAGE
9
Division of Filing Review
10