2015, Labelling and Packaging - Pharmacist Digest

Common pharma compliance concerns cited by FDA warning letters

European Pharmaceutical Review

AUGUST 23, 2022

However, the researchers noted that a larger number of warning letters were issued to pharmaceutical manufacturers (ie, by CDER) than to medical device manufacturers (by CDRH) between 2015 and 2020. The major reasons for this were poor cGMP compliance and misbranding.

Documentation

Documentation Pharmaceutical Manufacturing Packaging Labelling

September 2023 Newsletter

Safe Biologics

NOVEMBER 12, 2023

6 would prevent the HHS Secretary from requiring a switching study as part of the data package to receive the interchangeable designation. This is the first biosimilar approved to treat systemic juvenile idiopathic arthritis, and the 43rd biosimilar approved by the FDA since 2015. However, S.6 ASBM surveys of U.S.

FDA Issues Long-Awaited QMSR Final Rule

FDA Law Blog: Biosimilars

FEBRUARY 21, 2024

This amendment marks the first significant revision of Part 820 since 1996, which established the Quality System (QS) regulation and “included requirements related to the methods used in, and the facilities and controls used for, designing, manufacturing, packaging, labeling, storing, installing, and servicing of devices intended for human use.”

Labelling

Labelling Packaging Documentation

Drugs and Lactation

RX Note

JUNE 8, 2023

In the past, package inserts were not always reliable sources of information regarding medication safety during lactation. As a general rule, breastfeeding is considered acceptable when the relative infant dose is <10%.

Labelling

Labelling Packaging

Medication Safety

RX Note

OCTOBER 5, 2023

Such events may be related to professional practice and healthcare products, procedures and systems, including prescribing; order communication; product labelling, packaging and nomenclature; compounding; dispensing; distribution; administration; education; monitoring; and use.

Health and Personal Care Stores

Health and Personal Care Stores Labelling Packaging Compounding

Pharmacologic Management of Crotalid Envenomation

Pharmacy Friday Pearls

MARCH 9, 2022

Crofab ® [package insert]. Anavip ® [package insert]. in the treatment group vs 7.4 in the control group (95% CI 0.1 – 2.3; in the treatment group vs 7.4 in the control group (95% CI 0.1 – 2.3; Available at: [link] Accessed April 28, 2020. West Conshohocken, PA: BTG International Inc; 2000. Crotalidae Immune F(ab’)2 (Equine).

Immunity

Immunity Immunization Packaging Labelling

Navigating the unique CMC challenges of oral anaerobic live biotherapeutics

European Pharmaceutical Review

FEBRUARY 14, 2024

Flexibility in packaging and label design may also be necessary, particularly where the physical dose size may require to be modified due to potency variations or multiple units may requiring dosing to achieve the target dose. 2015; 69(1):381–403 5. Leveraging Quorum Sensing to Manipulate Microbial Dynamics. 2021; 19:100306 4.

Dosage

Dosage Packaging Labelling Compounding

Extemporaneous Compounding

RX Note

JUNE 5, 2023

A simple method is to use a small adhesive label to mark the position and thus produce a measure with just one graduation.) Furthermore, in late August 2020, the FDA approved labelling changes for hydrochlorothiazide (HCTZ) to inform clinicians and patients about the slight risk of developing non-melanoma skin cancer.

Compounding

Compounding Labelling Packaging Hospitals

Improving access to treatments in challenging markets

pharmaphorum

AUGUST 25, 2021

In 2015, PEPFAR reached out to Gilead and said they were working with the government in Sub-Saharan Africa. If you get past the regulatory hurdles, then you have to look at labelling requirements, packaging requirements, and quality assurance requirements.”.

Packaging

Packaging Labelling Compounding

10 Things To Do To Lower Your Toxic Burden

The Thyroid Pharmacist

SEPTEMBER 6, 2023

Personal Care : The Wellnesse line of haircare and toothpastes by Katie Wells (aka the “Wellness Mama”) contains high-quality, safe ingredients that are clearly labeled, so there are no surprises! They even have a trial package , so you can test their products out and see how they work for you! 27 April 2015. Endocrine Research.

Health and Personal Care Stores

Health and Personal Care Stores Packaging Labelling Compounding

Eric Halioua, President & CEO at PDCline Pharma Shares Insights on the Results from P-I/II Trial with PDClung01

PharmaShots

JUNE 1, 2023

We are conducting an open-label, dose-escalation, phase I/II study PDC-LUNG-101 assessing the safety, tolerability, immunogenicity, and the preliminary clinical activity of therapeutic cancer vaccine PDC*lung, associated or not with anti-PD1 treatment in patients with non-small-cell lung cancer (NSCLC). 2015; Zhu et al.,

Immunity

Immunity Immunization Vaccines Health and Personal Care Stores

Hashimoto’s and Graves’ Remission after Helicobacter Pylori Eradication

The Thyroid Pharmacist

AUGUST 19, 2022

In 2015, 80 percent of my clients who hit a plateau with nutrition and took the gut tests I recommended, tested positive for at least one gut infection. MegaGuard and PyloGuard provide doses on the package. doi: 10.1515/cipms-2015-0038. Published 2015 Jul 16. Gut Infections and Autoimmunity. 39,64-67). 2018; 28(1): 30-32.

Health and Personal Care Stores

Health and Personal Care Stores Immunity Immunization Dosage

Air Quality and Hashimoto’s – Is the Air You’re Breathing Making You Sick?

The Thyroid Pharmacist

JULY 29, 2022

Perhaps more concerning, of the 133 different VOCs found across all tested products, only one, ethanol, was actually listed on any label! (13, For sunscreens and other over-the-counter drugs, fragrances must be identified on the label. But formaldehyde has been labeled as a known human carcinogen by the U.S. Sinus problems.

Health and Personal Care Stores

Health and Personal Care Stores Compounding Immunity Immunization

9 Sneaky Thyroid Toxins Hiding in Your Home

The Thyroid Pharmacist

MARCH 7, 2025

to fluoride in my tap water, to hidden mold in my home, to my shampoo and deodorant (have you ever read those labels?!), 10] Its not only found in obvious sources like plastic containers and packaging, but also in the lining of canned foods and drinks, receipts, toys, electronics, and household items.

Health and Personal Care Stores

Health and Personal Care Stores Labelling Immunity Immunization

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