10 Before approving an NDA or BLA, the FDA will conduct a pre-approval inspection of the manufact f ur t ing facilities for the new product to determine whether they comply with cGMP requirements. The FDA will not approve the product unless it determines that the manufact f ur t ing processes and facilities are in compliance with cGMP requirements and adequate to assure consistent production of the product within required specific f ations. The FDA also may audit data from clinical trials to ensure compliance with GCP requirements. Additionally, the FDA may refer applications for novel drug r products or drug r products which present difficult questions of safety or effi f cacy to an advisory committee, typically a panel that includes clinicians and other experts, for review, evaluation and a recommendation as to whether the application should be approved and under what conditions, if any. The FDA is not bound by recommendations of an advisory committee, but it considers such recommendations when making decisions on approval. The FDA likely will reanalyze the clinical trial data, which could result in extensive discussions between the FDA and the applicant during the review process. Afte f r the FDA evaluates an NDA or BLA, it will issue an approval letter or a Complete Response Letter. An approval letter authorizes commercial marketing of the drug r with specific f prescribing information for specific f indications. A Complete Response Letter indicates that the review cycle of the application is complete and the application will not be approved in its present form. A Complete Response Letter usually describes all of the specific f deficiencies in the NDA or BLA identified by the FDA. The Complete Response Letter may require additional clinical data, additional pivotal Phase 3 clinical trial(s) and/or other significant and time-consuming requirements related to clinical trials, preclinical studi t es or manufactur t ing. If a Complete Response Letter is issued, the applicant may either resubm u it the NDA or BLA, addressing all of the deficiencies identifie f d in the letter, or withdraw the application. Even if such data and information are subm u itted, the FDA may decide that the NDA or BLA does not satisfy f the criteria for approval. Data obtained from clinical trials are not always conclusive and the FDA may interpret data differently than we interpret the same data. Expe x dite i d Developm l ent and Review Programs The FDA has a fast track program that is intended to expedite or facilitate the process for reviewing new drugs r and biologics that meet certain criteria. Specific f ally, new drugs r and biologics are eligible for fast track designation if they are intended to treat a serious or lifef threatening condition and preclinical or clinical data demonstrate the potential to address unmet medical needs for the condition. Fast track designation applies to both the product and the specific indication for which it is being studi t ed. The sponsor can request the FDA to designate the product for fast track status t any time before receiving NDA or BLA approval, but ideally no later than the pre-NDA or pre-BLA meeting. Any product subm u itted to the FDA for marketing, including under a fast track program, may be eligible for other types of FDA programs intended to expedite development and review, such as priority review and accelerated approval. Any product is eligible for priority review if it treats a serious or life-threatening condition and, if approved, would provide a significant improvement in safety and effe f ctiveness compared to availabl a e therapies. A product may also be eligible for accelerated approval, if it treats a serious or life- f threatening condition and generally provides a meaningful f advantage over availabl a e therapies. In addition, it must demonstrate an effe f ct on a surrogate endpoint that is reasonabl a y likely to predict clinical benefit or on a clinical endpoint that can be measured earlier than irreversible morbidity or mortality, or IMM, that is reasonabl a y likely to predict an effe f ct on IMM or other clinical benefit. As a condition of approval, the FDA may require that a sponsor of a drug r or biologic receiving accelerated approval perform adequate and well-controlled post-marketing clinical trials. If the FDA concludes that a drug r or biologic shown to be effe f ctive can be safely used only if distribution or use is restricted, it may require such post-marketing restrictions, as it deems necessary to assure safe use of the product. Additionally, a drug r or biologic may be eligible for designation as a breakthrough therapy if the product is intended, alone or in combination with one or more other drugs r or biologics, to treat a serious or life- f threatening condition and preliminary r clinical evidence indicates that the product may demonstrate subs u tantial improvement over currently approved therapies on one or more clinically significant endpoints. The benefits of breakthrough therapy designation include the same benefits as fast track designation, plus intensive guidance from the FDA to ensure an effi f cient drug r development program. Fast track designation, priority review, accelerated approval and breakthrough therapy designation do not change the standards for approval, but may expedite the development or approval process. Abbreviated t Licensure Pathway a of Biologi l cal Productst as Biosimilar or Interchangeablel The Biologics Price Competition and Innovation Act of 2009, or BPCIA, created an abbreviated approval pathway for biological products shown to be highly similar to an FDA-licensed reference biological product. An application for licensure of a biosimilar product must include information demonstrating biosimilarity based upon the following, unless the FDA determines otherwise: • analytical studi t es demonstrating that the proposed biosimilar product is highly similar to the approved product notwithstanding minor differences in clinically inactive components;