<h2 ss="wp-block-heading">The Amazing son inw Chapter 3879</h2>
Liam understood that James Smith might be dealing with some challenges, which is why he chose not to be upset about Smith’s tardiness. Instead, he responded with a nod and a friendly smile, saying, “It’s perfectly fine, Mr. Smith. I have no othermitments, so please don’t worry.”
“Thank you!” James replied with a polite smile as he took a seat across from Liam.<fn4343> ?????? ???? find{n}ovel</fn4343>
After casually ordering their meals, James inquired, “Is there something significant that brought Mr. Liam all the way from China?”
Liam smiled and replied, “You must have heard of Jiu Xuan Pharmaceutical, right?”
“Yes, I have,” Smith nodded. “You have a drug currently under review by our FDA, correct?”<h3 style="background-color:DodgerBlue">
“That’s right,” Liam responded quickly. “The review process has taken quite a while, and it hasn’t progressed to the next stage yet. I was hoping to ask if there might be a way to expedite it.”
Smith looked a bit ufortable and said, “The FDA has be quite stringent with its review of imported drugs. This process is indeed lengthy, and I can’t guarantee whether it meets our standards or if it will eventually be approved for sale.”
Liam borated, “Mr. Smith, our proprietary Chinese medicine consists of very safe ingredients, has no side effects, and boasts excellent efficacy. It can be described as having an immediate effect. Is there really a chance that the FDA would reject this medicine?”
Smith nodded and exined, “We have been receiving many drug applications from Eastern countries in recent years, particrly proprietary Chinese medicines. Not only from China, but also from Japan and South Korea. Unfortunately, many of these submissions have been rejected.”
Confused, Liam asked, “Why is that?”
Smith replied earnestly, “Mr. Liam, the requirements for testing and reviewing Western medicines differ significantly from those of Eastern traditional medicines. One crucial aspect is the necessity for a clear pharmacokic test.”
He continued, “You must specify the effective ingredient of the drug, its purpose, and its effects. Additionally, it’s imperative to inform us about any potential toxicity or side effects, particrly concerning the liver and kidneys, as well as the metabolic cycle of itsponents in the body. If these details are unclear, we will not allow it to enter the U.S. market.”
Liam quickly countered, “Many Kampo medicines have very intricate prescriptions, making their internalponents quiteplex. Unlike Western medicines, which often consist of a single active ingredient represented by a molecr form, Chinese patent medicines generally cannot meet Western requirements. Shouldn’t we aim formon ground while respecting our differences?”
Smith shook his head, stating, “I’m sorry, Mr. Liam, but at this juncture, we can’t pursuemon ground while reserving differences. The rules are firm. Essentially, all drugs entering the U.S. market mustply with all of our regtions; otherwise, they will not be approved for sale.”
Liam insisted, “Our medicine is highly effective and widely recognized by patients. It’s a top-selling medicine in many countries. I know that numerous American patients are purchasing our Jiuxuanweisan through intermediaries. However, this method is not only time-consuming but also expensive. They are eager for the FDA to expedite the approval process so they can ess it more easily.”
Smith shook his head again, “Many patients may not discern whether your medicine provides a clear therapeutic effect or merely alleviates symptoms temporarily. If it’s thetter, it may hinder the actual treatment of the underlying condition.”
He then added, “Take, for instance, a popr hemorrhoid suppository from China. Some patients in the U.S. have bought it through online shops and ck market channels. While it may offer a temporary feeling of relief, it has not received FDA approval for a reason. Do you understand why that is?”
Liam looked puzzled and asked, “Why is that?”<h2 ss="wp-block-heading">The Amazing son inw Chapter 3879</h2>