The FDA Law Blog

MARCH 21, 2024

As the new law unfolds—and as state laws regarding ingredients and packaging, as well as laws regarding environmental claims continue to affect the cosmetics and personal care industries—the topics covered at the conference have never been more relevant.

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The Checkup by Singlecare

JANUARY 18, 2024

in 2027 and other countries in 2025, when a generic version may be approved. intrauterine device of brand-name Skyla See latest prices Heather (norethindrone) $46 per 1 package of 28, 0.35 mg tablets $5 per 1 package of 28, 0.35 mg tablets $5 per 1 package of 28, 0.35 Is Nexplanon covered by insurance?

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Pharmaceutical Technology

APRIL 21, 2023

While the FDA sent Lilly a complete response letter detailing issues pertaining to the proposed manufacturing of mirikizumab, the regulator raised no concerns about the clinical data package or label for the medicine. The recent setback dents mirikizumab’s chances to be the first among the IL-23 inhibitors to launch in the US for UC.

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European Pharmaceutical Review

SEPTEMBER 15, 2022

The plant is specialised in the purification and filling of plasma-derived therapies, with packaging capabilities for a variety of plasma treatments. People with these conditions may require lifesaving treatment for acute emergencies, as well as lifelong substitution therapy.

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Packaging 89

Pharmaceutical Technology

NOVEMBER 22, 2022

The Chinese government announced its ten-year 'Made in China 2025' strategic plan in 2015, which aimed to make the country a global leader in several high-tech industries. These industries unexpectedly also included biotech, which was not a particularly strong area for Chinese manufacturing, which is more recognised for generics production.

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Pharmaceutical Technology

JULY 29, 2022

Injectables and their packaging requirements have never been more important to marketed treatments, given the volume of vaccines being packaged that are required to tackle the Covid-19 pandemic, as well as the rising presence of biologics in pipelines and their marketed approvals. with BARDA (Washington DC).

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Vaccines Packaging Immunization FDA 52

The Checkup by Singlecare

NOVEMBER 3, 2023

The 2020–2025 Dietary Guidelines for Americans recommend that Americans limit the amount of sugar they consume to less than 10% of their daily intake of calories. When buying packaged foods, carefully scan the label and look for added sugars. Experts suggest restricting your intake of added sugars. Read food labels carefully.

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Labelling Packaging Immunization 116

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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BuzzRx

AUGUST 30, 2022

This law includes a broad package of provisions concerning healthcare, taxes, and climate change. Then, in 2025 the law will add a $2,000 cap on spending. This will include eliminating coinsurance above the catastrophic threshold in 2024, followed by the addition of a $2,000 cap on spending in 2025.

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Vaccines Insurance Packaging Immunization 52

ISPE

OCTOBER 26, 2022

We defined the path forward for 2023–2025 after a final round of consultations with the Board advisors in July. In addition, we took the Board on tours of Vetter’s facilities for sterile products and through all the production steps: compounding to fill-finish to automated visual inspection and secondary packaging.

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Packaging Compounding Communication Vaccines 52

PharmaShots

FEBRUARY 1, 2023

and nurse support services & pharmacy support services to eligible patients. The biosimilar will be used to treat and prevent osteoporosis and cancer-related skeletal complications Under the terms of the agreement, HK inno.N no significant difference b/w groups in BCVA @6 & 12mos.

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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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Health and Personal Care Stores Vaccines Packaging Documentation 52

STAT

SEPTEMBER 23, 2022

… The White House is pitching an added benefit to the recent drug-pricing reform package: lower cancer death rates , STAT explains. A  A new analysis by the Council of Economic Advisers focused on a provision that caps Medicare out-of-pocket costs for pharmacy drugs at $2,000 a year, starting in 2025.

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Packaging FDA 79

ISPE

MARCH 6, 2023

9 In November 2022, the Chinese Pharmacopoeia announced the intention to include a chapter on ambient WFI in the 2025 edition. solvent selection, inhaler propellant replacement, and packaging design) to employee travel and commute policy (e.g., recycled content in packaging, reduction of packaging weights).

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Pharmaceutical Technology

MAY 23, 2023

While a handful of incentives are offered by the reform package, they are overshadowed by the potential drawbacks for the innovative sector. The passage of legislation is not anticipated before the next EU parliamentary elections in 2024, potentially resulting in delays until late 2024 or even 2025.

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Pharmaceutical Companies Pharmaceutical Companies Packaging 52

European Pharmaceutical Review

FEBRUARY 7, 2023

From 31 January 2025, new and ongoing clinical trials in the EU must be conducted in compliance with the CTR. Authorisation of the clinical trial, may, however, be obtained later. The proposed revisions will form the basis of the future regulation of the pharmaceutical industry in the EU and are anticipated for publication in mid-March.

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Packaging 96

Pharmaceutical Technology

NOVEMBER 1, 2022

“The medicines regulators in Europe have a strategy for 2025 where the second pillar is data and digitalisation, so we are trying to transform medicines regulation to be data-driven,” says Peter Arlett, Head of Data Analytics and Methods Task Force at EMA. Arlett explains that Darwin EU is playing a collaborative role in this goal.

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pharmaphorum

DECEMBER 13, 2021

It, too, announced plans to invest $500 million in a new facility in Africa for the production, fill/finish and packaging of mRNA vaccines. The company also presented results in November for their AstraZeneca-partnered mRNA candidate for heart failure. Some of that funding will go towards expanding the mRNA team to 400 staff.

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PharmaShots

JUNE 1, 2023

These new results reinforce our differentiating data package for PDC*lung01. After the completion of the current clinical study with PDC*lung01 (PDC-LUNG-101), we plan to conduct a randomized, open-label phase 2 clinical trial with PDC*lung in the B2 cohort setting (2025 to 2028).

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Immunization Vaccines Health and Personal Care Stores Labelling 40

PharmaShots

JUNE 7, 2023

Amgen will be allowed to sell its ustekinumab biosimilar no later than Jan 2025 Amgen highlighted the preliminary results from a P-III study which showed no clinical differences b/w ABP 654 and Stelara in adults with mod. PsO Ustekinumab, an anti-IL-12/IL-23 Ab drug indicated to treat PsO, PsA, CD, and UC.

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STAT

SEPTEMBER 23, 2022

WASHINGTON — The White House is pitching an added benefit to Democrats’ recent drug pricing reform package: lower cancer death rates. A new analysis by the Council of Economic Advisers focused on the new law capping Medicare patients’ out-of-pocket costs for pharmacy drugs at $2,000 per year, starting in 2025.

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Packaging 86

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. During the Covid-19 pandemic, large-scale vaccine production placed unprecedented demand on the parenteral packaging industry.

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