Pharmaceutical Technology

MARCH 22, 2023

According to the GlobalData report Contract Injectable Packaging Trends in the Bio/Pharma Industry , more than half (55%) of FDA drug approvals in 2021 were accounted for by injectables. This was higher than the number of approvals in 2019 and 2020. There are additional risks to consider with parenteral packaging.

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ISPE

MARCH 8, 2023

The cases covered the same types of contaminants and impurities noted in Table 1: microbial contaminants, process-related im-purities, metal contaminants, packaging-related contaminants, drug cross-contamination, and an “unknown” category encompassing other contaminants associated with the manufacturing process, including those from cell culturing.

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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). These new operating models can help enable and accelerate the efforts of Pharma 4.0™

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The FDA Law Blog

SEPTEMBER 30, 2024

Another rejected proposal was a definition of “vaccine” (vaccines are exempt from Medicaid rebates), which would have limited this term to a product that is administered prophylactically – i.e., to prevent rather than treat a disease. The most noteworthy are the following: 1. See 42 U.S.C. 1396r-8(b)(3)(C)(iii).

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PharmaShots

MARCH 9, 2023

She has also been awarded Crain’s Notable Women in Healthcare in 2019. Award & Nominations: Karen was one of the top 50 corporate American women in 2019 according to Black Enterprise magazine. Designation: Global Head Previous company: Merck Global Vaccines (2 yrs. She was also selected as the 39th Robert S.

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PharmaShots

APRIL 25, 2023

In 2019, Mallinckrodt entered into a collaboration agreement with Silence Therapeutics to develop and commercialize RNAi therapeutics to treat life-threatening unmet diseases. Through the 2019 agreement, Mallinckrodt received the exclusive worldwide license to Silence’s SLN500. R&D Expenditure: $6.6B

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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. Published November 2019. Published November 2019. Common Technical Document [CTD] sections). 5 Ahluwalia, K.,

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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. Published November 2019. 9 Lo Surdo, J. Cauchon, C. Ramdas, and E. Zavialov. “A

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ISPE

JANUARY 10, 2023

Both the development of COVID-19 vaccines and monoclonal antibody therapies and supply chain shortages related to the pandemic have affected sup-ply of the essential filters and chromatography resins used in the manufacture of biological products. Four proposed data packages and submission strategies follow.

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BuzzRx

AUGUST 30, 2022

This law includes a broad package of provisions concerning healthcare, taxes, and climate change. Cost sharing for adult vaccines covered by Medicare Part D will be eliminated In 2020, more than 4 million Medicare beneficiaries received a vaccine covered under Part D, including 3.6 million who received the shingles vaccine.

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