The FDA Law Blog

JANUARY 15, 2024

This story goes back to the 2009 Family Smoking Prevention and Tobacco Control Act, which prohibits manufacturers from selling any “new tobacco product” without authorization from FDA. Nor did FDA give notice that favored product manufactures had to submit robust scientific studies on flavored cigarette products.

FDA 115

FDA Documentation 115

pharmaphorum

DECEMBER 30, 2020

Soriot confirmed that AZ should be able to provide enough vaccine to meet the UK government’s target of a million doses per week “very rapidly” with the first doses due to be delivered to clinics “today or tomorrow.”. The companies have previously said they will be able to supply up to 1.3 billion doses worldwide by the end of 2021.

Vaccines 98

Vaccines Hospitals 98

ISPE

SEPTEMBER 11, 2023

In comparison to traditional large-scale manufacturing operations, decentralized modes of manufacturing can be more agile, more transportable, and tailored for specific modalities or production processes. 10 Similarly, POC manufacturing describes production at or near the location of the patient.

Health and Personal Care Stores 52

Health and Personal Care Stores Vaccines Packaging Documentation 52

ISPE

SEPTEMBER 8, 2023

Most important, the lack of global regulatory harmonization reduces incentives for industry to invest in these innovations, which, in many ways, limits access of safe, effective, and quality drug products to patients globally. Results will be presented at meetings, summarized in blogs, and eventually issued in a report.

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FDA Dosage Documentation Communication 52

The Thyroid Pharmacist

MAY 19, 2023

6] Prolactin, released by breastfeeding women to promote milk production, may also become elevated in women with Hashimoto’s (even when they’re not breastfeeding), and has been tied to both increased thyroid antibodies and infertility. This can, in turn, impact your other hormone systems further.

Immunization 62

Immunization Insurance Compounding Insurance Coverage 62

ISPE

MARCH 6, 2023

These are a heterogenous class of GHG emissions associated with purchased goods and services to manufacture and distribute a given product. Indeed, many existing systems may struggle to meet internal room requirements due to ambient conditions exceeding the design limits. For pharmaceutical companies, purchased goods (e.g.,

Packaging 52

Packaging Pharmaceutical Companies Pharmaceutical Companies Compounding 52

ISPE

MARCH 15, 2023

While the term sustainability encompasses a wide scope of goals, in examining manufacturing environmental sustainability we address reducing environmental burdens and progressing to more circular economies throughout the product and manufacturing process life cycle. www.fao.org/faolex/results/en/?query=environment 7 An integrative (vs.

Packaging 52

Packaging Labelling Health Compliance Process Improvement 52

pharmaphorum

AUGUST 20, 2020

Regeneron is already working on ramping up manufacturing capacity for REGN-COV2, with the help of $450 million in funding from the US government, but has admitted that it won’t be able to meet the expected demand for the drug on its own. The post Regeneron recruits Roche to make COVID-19 antibody drug REGN-COV2 appeared first on.

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Immunization Vaccines FDA 57

The Thyroid Pharmacist

MARCH 10, 2023

Sunlight on our retinas helps activate morning cortisol production and helps set our circadian rhythm for the day. Candlelights and salt lamps, as well as certain red lights, can provide ample illumination for most evening activities, while still promoting melatonin production. This has been a big game-changer for my hubby!

Health and Personal Care Stores 68

Health and Personal Care Stores Immunization Packaging Dosage 68

ISPE

SEPTEMBER 10, 2023

Among global BoHs, variability in regulatory requirements and approval times for postapproval CMC changes has created an inordinately long delay between the first and last approval for a single CMC change for a pharmaceutical product. It also allows for comparisons between companies and across different periods of time.

Documentation 98

Documentation Process Improvement Packaging Pharmaceutical Companies 98