The FDA Law Blog

JULY 10, 2023

Performance Metric FY 2018 FY 2019 FY 2020 FY 2021 FY 2022 Average Number of FDA Days to MDUFA IV Decision 72.62 In this case, the FDA clock start date is determined as the date of receiving the submission by the Document Control Center (DCC). Attachment number) and document name or description as appropriate.

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ISPE

MAY 9, 2023

Improvements have been observed by various regulatory agencies in Latin America for the acceptance and implementation of international standards—for instance, the ICH Common Technical Document (CTD) format. Additional required information beyond ICH guidelines, or non-value-added documents (e.g., 6, and 2.3.S.7 7 are required.

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ISPE

AUGUST 29, 2022

For changes requiring approval before implementation, once the necessary information has been submitted across regions, each health authority must review the data package and documentation based on local requirements. laboratory notebooks, batch records, and technical reports) to submission documents (e.g.,

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European Pharmaceutical Review

JANUARY 25, 2024

These standardised documents provide meticulously curated and scientifically approved information. Article 63 EMA (29 January 2020). Within the EU, patient information leaflets (PILs) are not merely a regulatory requirement but a cornerstone of patient safety. 11 This requirement directly contradicts what is included in Article 63.

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Pharmaceutical Technology

APRIL 14, 2023

Although the organisation previously shared a draft version of the report in February, the revised document features new details on the drugs’ potential fair pricing. Obeticholic acid will be in the spotlight when an approval package for its use in NASH will be discussed at a Gastrointestinal Drugs Advisory Committee meeting on May 19.

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ISPE

MAY 11, 2023

The key to data integrity compliance is a well-functioning data governance system 1 , 2 in which the data flow path for all business processes and equipment—such as in manufacturing, laboratory, and clinical studies—is fully understood and documented by a detailed process data flow map. Many organizations already have documented process maps.

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ISPE

MARCH 7, 2023

As such there’s a growing question of how the industry will improve the sustainability profile of its existing medicines and ensure that sustainability is designed into new medicines, such as products, with a reduced environmental risk, greener manufacturing technologies, and recyclable delivery systems and packaging. 9 December 2021.

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pharmaphorum

JANUARY 18, 2022

million in 2020 and with the rapid growth of the industry, is expected to grow at a CAGR of 8.95% up to 2027. Primary Packaging material designers. Secondary packagers. Understand requirements to facilitate the documentation preparation needed to obtain a NB Opinion. Who should Attend: Drug-delivery developers.

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ISPE

MARCH 29, 2023

Concept Paper: M4Q(R2) Common Technical Document on Quality Guideline.” If elements such as these are adopted during the revision of ICH M4Q, this could influence global regulatory agencies to eliminate the requirement for custom Module 2 commitment documents. The authors propose using Module 2.3 Published 15 November 2021.

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ISPE

MARCH 29, 2023

Concept Paper: M4Q(R2) Common Technical Document on Quality Guideline.” If elements such as these are adopted during the revision of ICH M4Q, this could influence global regulatory agencies to eliminate the requirement for custom Module 2 commitment documents. The authors propose using Module 2.3 Published 15 November 2021.

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The FDA Law Blog

OCTOBER 5, 2022

The proposed rule is intended to align with current nutrition science, the Dietary Guidelines for Americans 2020-2025 and the 2016 nutrition labeling regulation (which also was intended to align with the Dietary Guidelines for Americans). As a result, there generally will be no incentive to fortify foods with certain beneficial nutrients.

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The Checkup by Singlecare

FEBRUARY 16, 2024

“Antioxidant” has become a hyper-common wellness buzzword, slapped on health food packages so often that many people don’t think twice about it. 10 potential health benefits of NAC Some of NAC’s uses are time-tested and well-documented, like its efficacy in treating acetaminophen overdose.

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ISPE

SEPTEMBER 11, 2023

4 , 5 Additionally, reducing shipping limitations—such as packaging, storage, and transportation durations—helps speed up patient access in certain instances while ensuring there is no negative impact to the product’s critical quality attributes (CQAs). 3 (2020):e2970. 16 June 2020. 10 (2020):1861–75. 34 Maschan, M.,

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PQA

JUNE 27, 2024

In parallel with measure development, PQA initiated a research project in 2020 to identify facilitators and barriers impacting specialty pharmacy prescription turnaround time. Pilot participants were provided a technical package containing all resources needed to accurately calculate the SP-TAT-PH measure.

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ISPE

AUGUST 30, 2022

In this article, the term “raw material” refers to a material used in the manufacturing and packaging of a drug substance (DS) or a drug product (DP). Finally, the DP is packaged in a suitable container to ensure continued quality. The absence of any of the listed documentation should be scientifically justified.

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The People's Pharmacy

MAY 8, 2023

“The FDA said Global Pharma failed to use adequate, tamper-evident packaging and distributed the drugs without proper preservatives.” There have been problems with records in the past: deceit, falsification of documents and even outright fraud. Visitors to this website report a number of generic drug problems.

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ISPE

SEPTEMBER 11, 2023

The setpoint for “proper” air velocity in cleanroom systems is documented in standards and regulations as 0.45 x, a free and open-source computational fluid dynamics (CFD) software package. link] The setpoint for “proper” air velocity in cleanroom systems is documented in standards and regulations as 0.45 m/s up to 0.54

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The Thyroid Pharmacist

JULY 29, 2022

I was inspired to write this blog after the September 2020 Cameron Peak fires in Colorado. Feel free to use my own health timeline as a guideline to document your health journey. Most filter manufacturers have pictures on their filter packaging that indicate what they will and will not filter, along with the MERV rating.

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pharmaphorum

FEBRUARY 2, 2022

As the COVID-19 pandemic ricocheted around the world at the start of 2020, researchers were faced with a stark choice – go remote or go home. Through a series of workshops and surveys, which collected the views of research professionals, patients and carers, the group has developed a new guidance document. A practical consensus.

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ISPE

SEPTEMBER 10, 2023

In these countries, a secondary packaging site change or an active pharmaceutical ingredient (API) manufacturing site addition triggers a new submission equivalent to that required for approval of a generic drug or a line extension, whereas these site changes may be filed as a notification in the US and EU.

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ISPE

JULY 6, 2023

3 , 5 , 6 Historically, the highest number of FDA approvals—60% of total marketed CM drugs—occurred from 2018 to 2020 (see Table 1) and although 2021 approvals decreased to pre-2018 levels, 2022 saw two approvals: 13% of total marketed CM drugs. 12 (December 2020):2874–89. Published 18 August 2020. doi:10.1021/acs.oprd.0c00383

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