As a drugmaker, don't "call back" when the FDA answers questions

We need to learn, we all cherish the opportunity to answer questions, and please ask the drug supervision teacher to understand
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What should I do if I encounter pharmaceutical regulatory issues that I do not understand?

First, online search, the defect is that most of what can be found are the past regulations, and the new ones may not be able to find the answer;

Second, leave messages in WeChat groups, circles of friends, and professional pharmaceutical forums.
The defect is that no one may be willing to answer, and no one may answer in line with the views of the drug administration;

Third, go to the official website of the Food and Drug Administration to leave a message for consultation.
The reply of the teacher of the Food and Drug Administration is authoritative, rigorous, and well-founded, and can be implemented as a guiding opinion
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The third method completely avoids the risks of the first two.
After all, when I encounter questions from on-site inspections, I can take out the Q&A page of the Food and Drug Administration to support my point of view
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In addition, other pharmaceutical companies can also directly quote similar problems, which is similar to what the teacher said in school, "Students, a certain student just asked a question, I think it is very common, and I will explain it to you

Why do you say "ever"? Because the Drug Administration is facing the message on the webpage, non-text has already begun to appear
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Netizens consulted the provincial bureau for the management of traditional Chinese medicine granules.

Source: Anhui Provincial Drug Administration

Netizens ask whether the original production line needs to be retained for the entrusted production, and reply "I have replied to your inquiry by phone
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Thank you for your understanding and support of our work

Source: Anhui Provincial Drug Administration

Netizens inquire about the conditions and procedures for obtaining a drug production license (B certificate), and reply "I have replied to your inquiry by phone

Source: Anhui Provincial Drug Administration

Netizens ask whether they are eligible to register for the examination of the drug administration system, and reply "I have replied to your inquiry by phone

Source: Anhui Provincial Drug Administration

Not to say that all of them are "reply by phone", and many are replied in the form of text

Source: Anhui Provincial Drug Administration

As a middle-aged person in the workplace, for the sake of efficiency, in fact, most of the communication is "can write, not talk"
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Not to mention anything else, in the text, a few words can describe things clearly, and in a call, they have to repeat it several times

Besides, online text reply, written language will be more concise and accurate, which can avoid misunderstanding and misjudgment due to inaccurate pronunciation during voice calls
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This is an optimization that promotes understanding for both parties

The black-bellied thought, there is only one possibility, the best is the voice, or even reply back then
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That is, one party does not want to leave traces, and does not want to use it as a follow-up basis
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I think the drug supervisor's reply by telephone is definitely not what he is considering
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But based on another point of consideration, the person who consulted was not described in detail enough, and the answering question had to fully grasp the incident itself, so they had to reply by phone
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This requires us to describe sufficiently comprehensively during consultation, so as not to cause trouble to the supervisor
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If too many inquiries are answered by phone, when others encounter the same problem, they can only leave a message for consultation
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This also increases some meaningless workload, which is a waste of energy for both parties
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I look forward to using more text messages to reply, so that the drug administration can play the role of publicity and guidance in answering questions and doubts, which will bring benefits to the efficiency and level of both parties
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