The Checkup by Singlecare

FEBRUARY 8, 2024

Food and Drug Administration (FDA) advisory committee met to discuss evidence suggesting that oral phenylephrine, one of the active ingredients found in most over-the-counter decongestants, is ineffective for relieving nasal congestion. However, the FDA has not yet arrived at a definite conclusion as the evidence is still under review.

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Pharmaceutical Technology

JUNE 9, 2025

Exxua, developed by Fabre-Kramer Pharmaceuticals, is a selective serotonin 5HT1a receptor agonist that has gained approval from the US Food and Drug Administration (FDA) for treating MDD in adults. Aytu is committed to royalty payments based on net sales as stipulated in their definitive agreement, including a product transfer cost.

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The FDA Law Blog

NOVEMBER 2, 2023

Lewis, Senior Regulatory Device & Biologics Expert — On October 20, 2023, FDA announced the availability of the final guidance authored by CBER titled “Voluntary Consensus Standards Recognition Program for Regenerative Medicine Therapies.” Tobolowsky & Richard A. It finalized a draft guidance published in 2022.

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The Checkup by Singlecare

DECEMBER 1, 2023

For people with Type 2 diabetes, Ozempic is a game-changer: This FDA-approved drug not only lowers blood sugar but can also help people lose weight. You know it’s important to avoid certain foods while taking Ozempic, but are there other foods you definitely should be eating? What should you eat while taking Ozempic?

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DiversifyRx

JULY 11, 2024

Small Dispensers and the 6/12/2024 FDA Announcement Concerning DSCSA This week’s article on the recent DSCSA postponement comes from PRS Pharmacy Services. If the FDA or another regulator requests DSCSA transaction data, the DSCSA regulations give you up to 48 hours to respond. The original article can be found HERE.

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European Pharmaceutical Review

MARCH 28, 2024

FDA is expected to provide initial feedback on the data submitted by July 2024, with further data to be collected and analysed over the next two years. What is the main reason submission of the DVA qualification to FDA is significant for future clinical trials?

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ISPE

MAY 11, 2023

The FDA, PIC/S, and WHO have all emphasized the importance and benefits of data flows in their guidance on data integrity. The goal is to break down complex processes into easy-to-grasp packages, including data privacy and information technology (IT) security. In the fourth and last step, the defined work packages are executed.

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STAT

FEBRUARY 21, 2023

WASHINGTON — General Mills, Kellogg’s, and the rest of the country’s cereal makers are mad at the FDA. So are the packaged food companies, the pasta industry, and the pickle lobby (yes, it exists).

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The Checkup by Singlecare

JULY 10, 2024

You’ve probably eaten seaweed as part of your favorite sushi dish before or even snacked on a package of dried seaweed from the shelf of your local health food store.

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Pharmaceutical Technology

FEBRUARY 23, 2023

Fraction absorbed is directly related to the solubility, dissolution, and permeability of a compound and is the amount of drug that enters the intestinal enterocyte in our gastrointestinal tract (FDA definition), whereas bioavailability (F) is the amount of drug in the systemic circulation able to have a therapeutic effect.

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The Checkup by Singlecare

JUNE 17, 2024

High thyroid hormone levels can’t be definitively established without a blood test. Thyro-Tabs Canine is a brand name for levothyroxine that has been FDA-approved for use in dogs. If one is missing from the package, ask the veterinarian for one. When a dog shows any symptoms of hyperthyroidism, call the veterinarian.

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The Checkup by Singlecare

SEPTEMBER 28, 2023

Follow these steps to try nasal irrigation for congestion: Prepare the nasal rinse solution by mixing saline with distilled water per the package instructions. That said, research backing its effectiveness as a decongestant is lacking—and you definitely shouldn’t stick garlic cloves up your nose.

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ISPE

MARCH 29, 2023

As part of the US Food and Drug Administration (FDA) QbD pilot 4 in 2005–2006, the need to convey how the control strategy is linked to the target product profile (TPP) and quality target product profile (QTPP) was discussed. Direct feedback from the US FDA on this pilot is shared in the discussion. Pharmaceutical Engineering 42, no.

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ISPE

MARCH 29, 2023

As part of the US Food and Drug Administration (FDA) QbD pilot 4 in 2005–2006, the need to convey how the control strategy is linked to the target product profile (TPP) and quality target product profile (QTPP) was discussed. Direct feedback from the US FDA on this pilot is shared in the discussion. Pharmaceutical Engineering 42, no.

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ISPE

MARCH 7, 2023

Net Zero Design Within the sustainable design community there is much discussion and debate over the practical definition of terms like net zero energy and net zero carbon. Building automation and monitoring systems must remain operational per FDA requirements. To infinity and beyond, indeed. cold room, 27,500 sq.

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Pharmaceutical Technology

JUNE 30, 2025

Torrent Pharmaceuticals, headquartered in Gujerat, India, has signed definitive agreements for the acquisition of a controlling stake in JB Chemicals and Pharmaceuticals (JB Pharma) from global investment firm KKR at an equity valuation of Rs256.89bn ($3bn) on a fully diluted basis. How will RFK Jr’s American dream for vaccines play out?

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European Pharmaceutical Review

AUGUST 10, 2023

Amidst numerous warning letters distributed by the US Food and Drug Administration (FDA) to pharmaceutical manufacturers in recent months, in July this year, the US regulatory body published its analysis on drug product quality in 2022. Eight FDA warning letters were handed to European companies in 2018. Edge Biologicals Inc.,

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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. ICH Q12: Implementation Considerations for FDA-Regulated Products Guidance for Industry.” Draft Guidance for Industry.

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Pharmaceutical Technology

JUNE 30, 2025

Robert Barrie June 30, 2025 Share Copy Link Share on X Share on Linkedin Share on Facebook While zoonotic origin is the most likely source of the virus, a report says a definitive conclusion is not possible. How will RFK Jr’s American dream for vaccines play out? Credit: Dalibor Sevaljevic via Shutterstock.

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European Pharmaceutical Review

NOVEMBER 14, 2023

In response to supply chain challenges, including shortages of critical glass vials for products like COVID-19 vaccines and parenteral drugs, the Packaging and Distribution Expert Committee (PD EC) has made a significant revision of United States Pharmacopeia (USP) General Chapter <660>—Glass.

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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. 1396r-8(k)(3). date of payment, date of shipment, date of invoice, etc.).

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Pharmaceutical Technology

JUNE 12, 2025

They have each committed to demanding definitive safety and efficacy data before making any new vaccine recommendations.” RFK Jr stated in an X post that: “All of these individuals are committed to evidence-based medicine, gold-standard science, and common sense. Give your business an edge with our leading industry insights.

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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). FDA Official Warns Manufacturers of Common Problems Found in Aseptic Operations.”

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The Luxe Pharmacist

JUNE 22, 2022

They are a European company and if you’re in pharmacy you may already know this but Europe holds much higher standards for OTC and cosmetics than we do here in the US by the FDA, so you already know the products are more tightly regulated and tested. Plus FRÉ goes a step further and only uses ingredients in the top tiers. you name it!

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ISPE

NOVEMBER 2, 2022

Pfizer was able to build close to two years of supply of products for the vaccine; it had to quickly scale up for producing billions of doses in a very short period of time, so Pfizer looked to ramp up drug substance, drug product, and packaging in many sites around the world in record time.

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PharmTech

JUNE 12, 2025

Silver Spring, MD, USA - June 25, 2022: The FDA White Oak Campus, headquarters of the United States Food and Drug Administration, a federal agency of the Department of Health and Human Services (HHS). Highlights of five of the seven letters, the companies they were addressed to, and the significant red flags found by FDA are presented below.

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ISPE

JULY 6, 2023

As of 2022, there were 15 drugs (see Table 1) manufactured using CM elements that have received FDA approval, with GSK, Pfizer, and Vertex owning approximately 60% of the market share, followed by Janssen/J&J with about 13%. Table 1: List of FDA-approved commercial products using CM elements.

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The FDA Law Blog

JANUARY 20, 2025

Nearly two years after FDA issued draft guidance on Labeling of Plant-Based Milk Alternatives and Voluntary Nutrient Statements , on January 6, 2025, FDA released draft guidance document on plant-based labeling, Labeling Plant-Based Alternatives to Animal-Derived Foods. The description or name of the food (i.e.,

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The FDA Law Blog

DECEMBER 6, 2024

Valentine On November 19, 2024, FDA released a draft guidance titled Frequently Asked Questions Developing Potential Cellular and Gene Therapy Products. Section #1: FDA Interactions Given the wide range of sponsors (i.e., The draft guidance recommends that no more than 15 questions are included in the briefing package.

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The Checkup by Singlecare

APRIL 14, 2025

How glipizide works Glipizide is FDA approved to treat Type 2 diabetes in combination with a healthy meal plan and regular exercise. While a glass of wine with dinner probably wont drastically affect your blood sugar, per the American Diabetes Association , a cocktail or multiple drinks on an empty stomach are definitely a no-go.

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