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2016年FDA指南文件计划的更多点评

首页 > 资讯 > 2016年FDA指南文件计划的更多点评

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2016年FDA指南文件计划的更多点评
指南计划
页面比对
笔记

2016-02-11 Lachman CONSULTANTS

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1月26日我们曾发布资讯关于FDA药品审评和研究中心(CDER)公布的将于2016年新起草和修订指南的日程计划,并挑选了一些指南稍作评论【识林资讯-2016年FDA计划新起草和修订指南日程】。下面我们挑选了今年可以期待的另外一些指南稍加点评,按分类列举如下:(完整的文件清单请见此处)

药品质量/生产标准(CGMP)
  • 《CGMP数据可靠性问答》 – 过去几年中许多CGMP发现与数据可靠性问题相关,这应该是一份非常有意思的文件。自仿制药丑闻以来,FDA还没有对数据可靠性问题采取强硬措施。MHRA也一直非常积极地基于在检查中发现的各种数据可靠性问题提供这方面的指南。
  • 《单位剂量重新包装固体口服制剂药品的有效期;修订草案》 – 这份古老的、经常被曲解的指南文件的修订,希望将新增一些关于FDA已表明立场的澄清。我能够告诉你的是过去这些年来,为了从FDA或企业其他人那里获得直接的答案,一直问了10个律师相同的问题,得到了15个不同的答案!
  • 《药房或外包设施对某些药品的重新包装》 – 我们不确定这份指南是更直接的指向与重新包装有关的配药/外包药房,而不仅仅是一般药房。
标签
  • 《防儿童开启的瓶盖和标签》 – FDA是时候解决这一问题了,我们相信标签需要标准化和可理解,以及什么时候对于什么产品必须包装在防儿童开启容器中。许多较老的ANDA对于这一问题可能不像我们希望的那样一致。
药品质量/CMC
  • 《已获批药品的可比性方案:化学、生产和控制信息;修订草案》 – 另外一份最终迎来更新的指南。也许在修订指南发布后,我们将在这一问题上达成“统一的质量声音”。
  • 《药物主文件;修订草案》 – 鉴于上一版DMF指南文件年代久远,很高兴迎来新版指南。
  • 《阿片类产品滥用遏制特性的体外评价方法》 – 整个行业需要澄清的关于滥用遏制产品的一系列重要指南文件之一。
  • 《定量吸入器(MDI)和干粉吸入器(DPI)药品 – 化学、生产和控制文件;修订草案》 – 你见过许多仿制药MDI或DPI吗?我不这么认为。我们需要我们能获得的所有指南,其中肯定要有一份反应当前FDA想法的指南。
  • 《非无菌药品生产中的微生物质量考虑》 – 这是另一个布满迷雾的问题,或许这份文件可以帮助企业在茫茫大海中标定航向。
  • 《药物共晶的监管分类;修订草案》 – 我不知道你是怎样的感觉,但当我阅读原始指南的时候,我在想“他们在说什么?”
  • 《FDA非活性成分软件(IID)的使用》 – IID将许多监管事务专业人员和配方者合并到一个12步的程序中。我们是否越来越接近一些有意义的修订了?
  • 《咀嚼片的质量属性考虑》 – 鉴于对儿科患者和老年人,或吞咽障碍患者的关注,对这一问题进一步的澄清和对剂型的定义将会有很大帮助。

请对这份指南日程计划中的所有指南文件保持关注。

Lachman CONSULTANTS - Bob Pollock先生
编译:识林-椒
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More on the New Guidance Documents FDA Plans to Issue in 2016
By Bob Pollock | February 10, 2016

On January 25, 2016, this blog posted an article about some of the Guidance documents that FDA was planning to issue as new and or revised this coming year (here). In that blog post, it was noted that an update to that post would be coming-well here it is!

Some of the other notable documents we can all be looking for this year (with a little bit of editorializing) include, by category:

Pharmaceutical Quality/Manufacturing Standards (CGMP)

  • CGMP Data Integrity Questions and Answers – This should be a very interesting document since many of the CGMP findings over the last few years have been related to data integrity issues. As I have noted previously, the FDA has not taken as an aggressive stance on data integrity issues since back in the Generic Scandal days! The MHRA has also been very active in regard to providing guidance in this area based on their findings of various issues of data integrity during their inspections. Lachman Consultants has been actively involved in data integrity training sessions and seminars recently and has been involved in assisting firms rehabilitate themselves where such problems have been uncovered.
  • Expiration Dating of Unit-Dose Repackaged Solid Oral Dosage Form Drug Products; Revised Draft – The revision of this old, often misinterpreted Guidance document hopefully will add some clarity about FDA’s stated position. I can tell you that over the years, getting a straight answer from FDA or others in industry has been like asking 10 lawyers the same question and getting 15 different answers!
  • Repackaging of Certain Drug Products by Pharmacies and Outsourcing Facilities – We are not sure whether this is more directed to compounding/outsourcing pharmacies than to just pharmacies in general, relative to repackaging. We will just have to see when it is issued!

Labeling

  • Child Resistant Closures and Labeling – It's about time the Agency addressed this issue as we believe that there needs to be standardization and understanding of labeling, as well as when and what products must be in Child Resistant containers. Many of the older ANDAs may or may notbe as consistent on this issue as we would have hoped.

Pharmaceutical Quality/CMC

  • Comparability Protocols for Approved Drugs: Chemistry, Manufacturing, and Controls Information; Revised Draft – Again, another document whose updating time has finally come. Maybe we will have “one quality voice” on this issue after the revised Guidance hits the street.
  • Drug Master Files; Revised Draft – Given the age of the last DMF guidance document, it will be nice to welcome its grandson to the table.
  • In-vitro Methods for Evaluation of Abuse Deterrent Properties of Opioid Products – Another in a series of important Guidance documents on abuse deterrent products for which the entire industry needs clarity.
  • Metered Dose Inhaler (MDI) and Dry Powder Inhaler (DPI) Drug Products – Chemistry, Manufacturing, and Controls Documentation; Revised Draft – What can I say – have you seen many generic MDIs or DPI? Didn’t think so. We need all the Guidance we can get and certainly one that reflects current Agency thinking.
  • Microbiological Quality Consideration in Non-Sterile Drug Product Manufacturing – Here is another issue that has been as clear as mud. Perhaps this will set the ship straight.
  • Regulatory Classification of Pharmaceutical Co-Crystals; Revised Draft – I don’t know about you, but when I read the original Guidance I thought, “what did they just say?”
  • Use of the FDA Inactive Ingredient Software (IID) – The IID has put many regulatory affairs professionals and formulators into a 12-step program. Are we getting close to some meaningful revisions?
  • Quality Attribute Considerations for Chewable Tablets – Given the interest in pediatric patients and the elderly, or patients with dysphagia, having additional clarification on this issue and defining what the dosage form really is will be a big help.

Well, that's it for now. Just keep your eyes peeled throughout the year for these and many other documents not specifically covered in this blog. The full list can be found here.

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