Express Pharma

JUNE 28, 2024

With a focus on redefining the pharmaceutical industry in the post-COVID era, PharmaLytica 2024 offered a platform for stakeholders to engage in discussions covering the full spectrum of pharma machinery and packaging, lab analytical and cleanroom solutions, and pharmaceutical ingredients. trillion, with Turkey ranking 21st.

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Packaging Biosimilars Labelling Vaccines 105

PharmaShots

APRIL 5, 2023

neovascular (wet) AMD Additionally, the availability of Byooviz could enable more patients to access this type of vision-saving therapy as it brings a sustainable and cost-effective anti-VEGF treatment to Canadian vision care Byooviz was approved in Canada for the treatment of multiple eye disorders.

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FDA Law Blog: Biosimilars

JANUARY 11, 2024

The FIE determination released in fall 2023 involves the Reference Product AbbVie’s Humira (adalimumab) and two interchangeable biosimilars—first approved is Cyltezo (adalimumab-adbm), filed by Boehringer Ingelheim Pharmaceuticals, Inc, which was followed by Abrilada (adalimumab-afzb), filed by Pfizer.

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Pharma in Brief

AUGUST 9, 2021

Generic drugs and biosimilars are not eligible for this application pathway. The Minister would also have the ability to suspend the sale of an individual lot where there is evidence that it would present an unacceptable risk to Canadians’ health and safety, rather than suspend the drug’s authorization. Biologic Drugs.

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FDA Law Blog: Biosimilars

JULY 10, 2023

We will then present an effective strategy to address FDA’s AI request in a timely manner. However, the strategy of addressing the AI request presented in the next section of this blog post applies to all three types of 510(k)s. Table 1 below shows the 510(k) submission process based on the MDUFA III Performance Goals.

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Express Pharma

DECEMBER 7, 2023

Bhanu said that now India needs to be able to anticipate future needs and work with all stake holders to create and implement strategies which will foster innovation and promote research in high value products such as antibiotics, biosimilars, oncology medicines etc.

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FDA Law Blog: Biosimilars

SEPTEMBER 27, 2023

The biggest changes are the addition of Type D and Initial Targeted Engagement for Regulatory Advice on CDER and CBER ProducTs (INTERACT) meetings to the four types already present (Types A, B, B (end of phase), and C), and the addition of additional meeting formats.

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FDA Law Blog: Biosimilars

MARCH 3, 2024

The legislation may be revised, and the below is not an exhaustive list of our questions and concerns, but at present we have several observations and questions about how the Act may be implemented and potential consequences.

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Packaging 102

FDA Law Blog: Biosimilars

SEPTEMBER 24, 2024

The appeal of distilling down the extensive process that goes into the decision to approve an application into a single package is easy to see, and some may be interested in only the ultimate distillation – an approval is issued or not. There are those who are willing to read through the more extensive package consisting of all the reviews.

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Pharmaceutical Technology

DECEMBER 9, 2022

Beyond our expertise in small molecules, we have built a solid reputation with biopharmaceutical companies for the characterisation and analysis of monoclonal antibodies, therapeutic proteins and biosimilars. However, messenger RNA (mRNA) based vaccines present particular analytical challenges. HQ ADDRESS: Römerpark 2. Switzerland.

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PharmaShots

FEBRUARY 27, 2023

The theme of the event was Innovation, Advanced Technology, Current Challenges & Opportunities in Pharma & Healthcare Industry under which a series of presentation sessions and panel discussions were held related to pharma trends, APIs, policy reforms, AI, metaverse, current regulatory trends and the direction of pharma and drug discovery.

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FDA Law Blog: Biosimilars

AUGUST 17, 2023

The difference at issue here is the fact that Vanda’s Hetlioz product includes braille writing on its packaging, with some accompanying language (“Do not cover Braille”), and the generic products’ labeling does not. Moreover, other information, such as dosing instructions and warnings, were not presented in braille. . § 314.94(a)(8)(iv),

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RX Note

FEBRUARY 23, 2023

Threadworm - Night-time perianal itching is the classic presentation Oral Thrush - Unusual in healthy adults Faecal Incontinence - Unintentional passage of stool Pouching Systems - Available as one-piece or two-piece systems Eye Dry Eye - Evidence of superior efficacy among any of the ophthalmic lubricants is lacking.

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HIV Treatment and Prevention Agents Community Pharmacies Labelling Chemotherapy 58

FDA Law Blog: Biosimilars

MARCH 30, 2025

Encouraging Transparency : FDA is working closely with manufacturers to ensure clearer labeling and increased transparency regarding ingredients and nutritional information on formula packaging. Curiously, the announcements make no reference to the Long-Term National Strategy to Increase the Resiliency of the U.S.

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FDA Law Blog: Biosimilars

JANUARY 20, 2025

In the absence of a common or usual name or other name established by federal law or regulation, food sold in packaged form must be labeled with an appropriately descriptive term or a fanciful name commonly used by the public. For foods that do not have established definitions and standards of identity (i.e.,

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Labelling Documentation Packaging 52