Informal Communications with Regulatory Agencies

by | Apr 26, 2019 |

The formal meetings between the regulators and the applicant or sponsor occur at various phases of drug development. Before conducting such meetings, there should be an adequate basis for the need of meeting. Sometimes these meeting can be refused if the regulator feels it is premature for the drug development stage. But still the sponsor or applicant may need to communicate with regulator, and for this, there is a provision for informal communications such as INTERACT meeting with Center for Biologics Evaluation and Research (CBER). In the INTERACT meeting, the applicant or sponsor can consult informally with the agency at the early stage of drug development before the pre-IND meeting. The regulators provide simplified guidance on chemistry, manufacturing and controls, clinical aspects of the drug development program, and/or pharmacology/toxicology which helps the applicant to submit relevant and quality data. Before, arranging an INTERACT meeting, the sponsor has to select an investigational product or a product-derivation strategy to be evaluated in the clinical program. An informal communication with the regulators helps to eliminate any confusion regarding the submission/approval process and to produce better submissions. The applicants, however, must be mindful of good communication practices as set forth by regulators such as Food and Drug Administration (FDA).

A good and frequent communication can make the developmental process more efficient; however, communication alone cannot guarantee drug approval. The applicant after communicating with the regulators may get complete information about the quality data and clarification on the guidelines, but without proper presentation of that data, drug approval may not be achieved. Regulatory bodies are quite strict about regulatory submissions, as evident by a plethora of FDA guidelines. The data produced might be of the high quality, but without a well-written document per guidelines to present that data, the impact of that data on regulators get diminished. A poorly written document might increase the number of queries from the regulators. The regulators may not be able to identify key data and might even misinterpret the data in a poorly written document which will delay approval of the drug. The document might also require revisions multiple times leading to waste of time and money of the applicant.

A well-written document presents data in a well-structured form with a conclusion at the top that makes review process easy and approval process faster. A well-written document also produces lesser queries from the regulators and requires lesser or no revisions before approval. This makes evident the need for well-written regulatory documents. To create these documents, professional regulatory writers who are specialized in the creation of these documents are required. A regulatory writer must have a good knowledge of regulatory writing guidelines. In addition to this, a regulatory writer should have the ability to analyze the data. Regulatory writers combine knowledge of regulations with a knack for writing. A good writer produces high-quality submission documents which surely decrease the time and capital investment of the applicant. Thereby, by utilizing professional regulatory writers applicant can decrease approval time and investments for a drug.

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