I have a Banshee that I can either recalibrate to add +5% raw dmg, add +3% dmg to target out of cover, or recalibrate dmg to target out of cover to +6% armor damage. The Banshee’s current stats are 93.3k weapon dmg, 60% CHC AND 105.8%CHD. Core attributes are +10% SMG Damage, +18.5% CHC and +7% DMG to target out of cover.

The Division Difference Dmg To Target Out Of Cover Rangers
The Division Difference Dmg To Target Out Of Cover Ranges
The Division Difference Dmg To Target Out Of Cover Range Chart

Issued by:

(February 18, 1997)

Deal an extra 1d6 radiant damage to any target, and only if the target is a dragon do an additional 2d6 radiant damage (i.e. For a total of 3d6 additional damage). As with other modifiers the IFT statement can be chained.
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+5% DMG to target out of cover. Classified Set Bonus (6): Talent: Improved Banshee. While rogue, the time to clear manhunt status is decreased by 5% for every group member within 10 meters. All rogue status actions that result in a rank up are doubled. Rewards for clearing manhunt status are improved.

All NDA, ANDA, and AADA Holders

Dear Sponsors:

On November 30, 1995, the Scale-up and Post-Approval Changes Guidance for Immediate Release Products (SUPAC-IR) was published. Since then a number of questions have arisen in interpreting the Guidance as it applies to specific situations encountered or that could be encountered in the pharmaceutical industry. The purpose of this letter is primarily to share with you the questions that have been asked most frequently or that we consider the most significant. Also included are the Center's responses to these questions. The responses were developed and concurred with by the Office of New Drug Chemistry and Office of Generic Drugs, Center for Drug Evaluation and Research (CDER). We believe the sharing of the information will result in furthering the use of the Guidance to increase regulatory flexibility for industry.

In addition, the Center's Chemistry and Manufacturing Controls Coordinating Committee (CMC CC) has met and reconsidered two SUPAC-IR issues which have been of great concern and interest to industry. The following information on stand alone packaging operation site changes and stand alone analytical site changes represents a re-assessment of how SUPAC-IR should be interpreted on these issues.

STAND ALONE PACKAGING OPERATIONS SITE CHANGES

For immediate release solid oral dosage forms, a stand alone packaging operations site change, utilizing container(s)/closure(s) in the approved application, may be submitted as a Changes Being Effected supplement. The facility should also have a current and satisfactory cGMP compliance profile with FDA for the type of packaging operation in question before submitting the supplement. The supplement should contain written certification from the packaging facility stating that it is in conformance with cGMP's. If the facility has not received a satisfactory cGMP inspection within the previous two years for the type of packaging operation involved, a prior-approval supplement with the same commitment for stability is recommended.

The supplement should also contain a commitment to place the first production batch of the product on long-term stability studies using the approved protocol in the application and to submit the resulting data in annual reports. Where the product is available in more than one strength, size, or container/closure system, one batch of each combination should be placed on long-term stability studies. Bracketing or matrixing is allowed only if it has been approved previously by FDA. Any changes to an approved stability protocol should have a supplemental approval prior to the initiation of the stability study. Batches should be tested annually as per the stability commitments in the approved application.

STAND ALONE ANALYTICAL TESTING LAB SITE CHANGES

For immediate release solid oral dosage forms, a stand alone analytical testing laboratory site change may be submitted as a Changes Being Effected supplement, if the new facility has a current and satisfactory cGMP compliance profile with FDA for the type of testing operation in question. The supplement should contain a commitment to use the same SOP's and test methods employed in the approved application, written certification from the testing laboratory stating that they are in conformance with cGMP's, and a full description of the testing to be performed by the testing lab. If the facility has not received a satisfactory GMP inspection within the previous 2 years for the type of testing involved, a prior-approval supplement is recommended.

The CMC CC and the Center intend that the SUPAC-IR Guidance will be revised to further clarify and update its recommendations and to assure good correspondence between these recommendations and those of other SUPAC documents in preparation. In the meantime, we hope these questions and answers will help clarify the application of the Guidance.

Sincerely yours,

/s /

The Division Difference Dmg To Target Out Of Cover Rangers

Roger L. Williams, M. D.
Deputy Center Director for Pharmaceutical Science
Center for Drug Evaluation and Research

Enclosure

SUPAC-IR: QUESTIONS AND ANSWERS

(To the extent these questions and answers provide guidance, that guidance was prepared by the Chemistry, Manufacturing, and Controls Coordinating Committee in the Center for Drug Evaluation and Research (CDER) at the Food and Drug Administration. Although this guidance does not create or confer any rights for or on any person and does not operate to bind the FDA or the industry, it does represent the Agency's current thinking on questions related to the Scale-Up and Post-Approval Changes Guidance for Immediate Release Products (SUPAC-IR). An electronic version of these questions and answers are also available via Internet using the World Wide Web (WWW). To access the document on the WWW, connect to the CDER Home Page and go to the 'Regulatory Guidance' section.)

COMPONENT AND COMPOSITION CHANGES

1. Q: May one color be replaced with another by placing the batch on concurrent stability and reporting it in the annual report?A: A change from one color to another should be submitted as a prior approval supplement.2. Q: Can color be changed under SUPAC-IR?A: Yes. A change in color, either in amount or from one color to another, is a level 3 component and composition change which calls for a prior approval supplement. However, if the color is merely being removed, it is a level 1 change and can be reported in the next annual report.3. Q: What is the full definition of a change in 'technical grade' of an excipient? Does this only mean a change in excipient specifications that may impact functionality or does it include a change in supplier even if all applicable specifications remain the same? A: Technical grades of excipients differ in their specifications and intended use. Technical grades may differ in: 1) specifications and/or functionality; 2) impurities; and 3) impurity profiles. If a supplier of an excipient changes but its technical grade AND specifications remain the same, the agency should be notified in an annual report.4. Q: How does one apply SUPAC-IR to multifunctional excipients, e.g., starch?

A: SUPAC-IR composition changes are based on being able to define the use or action of the particular excipient in the product. This rationale should be included by the applicants as part of their original applications. Not all multifunctional excipients are listed in the guidance. However, if an excipient was utilized to provide multiple functions such as pregelatinized starch as a filler, starch as a disintegrant, starch paste as a binder, then the most conservative recommended change should be followed (e.g., for an excipient that is a filler, disintegrant and binder, the recommended limit for a Level 2 change is ' 0.5 percent, see page 7, SUPAC-IR). An applicant may wish to add an explanation of how the change will affect other functions of the excipient in the product. If this information was not included in the original application, the review division should be consulted before filing such a SUPAC change, either through a CBE or annual report.

5. Q: What is the reference source for defining the action of an inactive ingredient, for example, l