To: FDADockets@OHRM-MAIL@FDAOC

From: \<efox@schein-rx.com\>

Certify: Y

Subject: UNDEFINED

Date: Wednesday, September 9, 1998 at 11:47:05 am EDT

Attached: 98n-0339.doc

(See attached file: 98n-0339.doc)

Please open the attached Word document. If you have any problems opening

the attachment, please contact:

Davis R. Reese

Executive Director, Regulatory & Scientific Affairs

Marsam Pharmaceuticals

P.O. Box 1022

Cherry Hill, NJ 08034

Direct 609 489-5262 Main 609 424-5600

Thank you very much.

September 9, 1998

Dockets Management Branch (HFA-305)

Food and Drug Administration

5630 Fishers Lane, Room 1061

Rockville, MD 20852

Re: Docket No. 98N-0339

Section 406(b) of the FDA Modernization Act of 1997

These comments apply to questions 5 and 6 on page 39878 of the FR
Notice.

FDA can simultaneously substantially reduce its burden in the
application review process (question 5) and eliminate backlogs (assuming
no further substantial cuts in manpower until the changes have been
fully implemented) (question 6) if it focuses reviews on what is
different in the application under current review instead of rereviewing
what it has already found satisfactory in prior reviews for that
applicant. Using this approach, applications covering dosage forms
already approved for the same applicant should require at least 1/3 less
review time, with even more timesavings in many cases.

FDA has persisted with its long outmoded insistence that every
application be complete in itself. Manufacturers often reuse essentially
the same processes for manufacturing a new product that they use for
products already FDA approved. Even control methods are often used
across many products. In some cases, e.g., where the active ingredient
is the same, except for minor variations, the control processes are
identical to those already FDA approved. If FDA's goal is modernization,
it needs to completely address redundency in its review processes and
make radical improvements where it can.

1\. FDA should mandate the use of DMFs for common processes. This is the
direct opposite of FDA's goal to eliminate such DMFs. With the advent of
electronic filings next year, electronically filed DMFs could be easily
referenced by anyone at FDA and updated by applicants. In applications,
the common processes should be very briefly described with their DMF
numbers given. The current application would then cover/justify
variations, if any (e.g., the product is only aseptically filled, when
the DMF covers aseptic filling + terminal sterilization).

Approval of these DMFs is an important part of this time reduction. If
FDA reviewers cannot rely on an "approved" DMF, they will spend
unnecessary time rereviewing it. Suggestion: FDA should specify a
maximum time before the DMF must be either updated or a notice filed
that the DMF remains current (this time should be based on the date of
the original filing or, when revised, the most recent update or
notification that the DMF remains current).

2\. A section in the front portion of the application would specify
every variation and identify where each, with its justification, is
located in the application. If needed, a flow chart or other means of
overview could also be included.

3\. Use of this practice will also provide significant reduction in on
site inspection time by

FDA Investigators. This includes pre-approval inspections and
inspections for other purposes where manufacturing processes and/or
control procedures need to be reviewed.

Any comments/questions concening the above comments should be addressed
to:

Davis R. Reese

Executive Director, Regulatory & Scientific Affairs

Marsam Pharmaceuticals

P.O. Box 1022

Cherry Hill, NJ 08034

Direct 609 489-5262 Main 609 424-5600

The opportunity to comment and FDA's efforts to improve its review
processes are

appreciated.

Sincerely yours,

Davis R. Reese /s/ 9/9/98

Executive Director, Regulatory & Scientific Affairs

cc: S. Brown

R. Castellucci

W. McIntyre

F. Sayeed