FDA Law Blog: Biosimilars

JULY 15, 2025

FDA Law Blog is a conference media partner. Whether you’re navigating the impact of delayed MoCRA implementation or responding to increased scrutiny on marketing practices, this conference is your one-stop shop for industry perspectives and actionable compliance tools. As such, we can offer our readers a special 10% discount.

Packaging

Express Pharma

APRIL 6, 2023

This can include everything from product testing and labelling to marketing and advertising requirements. Challenge 4: Quality control and safety concerns Nutraceutical startups must ensure that their products meet quality and safety standards, as well as comply with labelling and advertising regulations.

Labelling

FDA Law Blog: Biosimilars

JUNE 26, 2024

eSTAR Templates As we have previously explained in our blog post here , eSTAR is an interactive PDF form designed to assist users in creating “complete” submissions. package labeling is optional). It includes questions about the product, that when answered, reveal additional information that should be supplied with a submission.

Labelling

Pharma Marketing Network

AUGUST 9, 2023

In this blog post, we will explore best practices for pharmaceutical companies to navigate the complex landscape of regulatory challenges in marketing. Adhere to Labeling and Packaging Requirements The labeling and packaging of pharmaceutical products are tightly regulated to ensure safety and accurate information.

Labelling

FDA Law Blog: Biosimilars

FEBRUARY 21, 2024

The long-awaited final rule, which we last discussed in a July 2023 blog post and have tracked in our March 2023 and March 2022 posts, aims to harmonize quality management system requirements for medical devices with requirements set forth by other regulatory authorities around the world. Notably, Part 820 will look different.

Labelling

pharmaphorum

OCTOBER 27, 2022

Blogs – A company is free to own a blog or engage a blog writer by way of sponsorship or consultancy fees. In the EU and UK, where direct-to-consumer promotion of POMs is prohibited, companies may not sponsor blogs that promote, or could reasonably be expected to promote, such products.

Communication

FDA Law Blog: Biosimilars

MARCH 27, 2023

Such codes need to be placed on device labels and packages to allow devices to be easily identified and tracked throughout their lifecycle, except where the rule provided for an exception or alternative. Devices can have both a UPC code and a UDI on their label and package. Emphasis added.)

Labelling

Express Pharma

JUNE 2, 2023

As part of these efforts, the government has implemented regulations mandating API (active pharmaceutical ingredient) manufacturers and pharma brands to incorporate barcoding on product packaging. This regulatory step is aimed at preventing falsified medicines from entering the market.

Adverse Reactions

FDA Law Blog: Biosimilars

JULY 10, 2023

In this blog post, we will first briefly outline the procedural steps in the 510(k) review process for medical devices. 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. FDA Day (in calendar days) FDA Actions Day 1 FDA receives 510(k) submission.

Documentation

Pharma Marketing Network

AUGUST 9, 2023

In this blog post, we will explore best practices for pharmaceutical companies to navigate the complex landscape of regulatory challenges in marketing. Adhere to Labeling and Packaging Requirements The labeling and packaging of pharmaceutical products are tightly regulated to ensure safety and accurate information.

Labelling

Express Pharma

JUNE 28, 2023

Other related technologies such as scanning barcode labels on packages have also facilitated electronic purchasing and procurement on a larger scale. However, a management system can help ensure the security and availability of all medicine stocks, resulting in cost savings.

Online Pharmacies

Express Pharma

SEPTEMBER 8, 2023

What use does the label serve, and who is responsible for making sure the QR code is still working when it changes commercial hands? What assurance is there that counterfeiters who can easily mimic a brand’s packaging, name, and logo won’t also be able to mimic its QR codes? It is useless if the QR codes are broken.

Packaging

FDA Law Blog: Biosimilars

JUNE 12, 2023

The Federal Food, Drug, and Cosmetic Act (FDC Act) requires that all animal foods, like human foods, be safe to eat, produced under sanitary conditions, contain no harmful substances, and be truthfully labeled. AAFCO also publishes model regulations, including model pet food labeling regulations which states may adopt.

Labelling

Pulses

AUGUST 31, 2023

Pulses is a scholarly blog supported by Currents in Pharmacy Teaching and Learning Tracy leads the Empathy Initiative and the ‘Research Inspired Pedagogy, Practice, and Educational Development’ (RIPPED) research groups. She has written ten books and over 200 journal publications.

Medication Dispensing

National Association of Boards of Pharmacy

APRIL 10, 2024

This blog post is continued from Preparing for an Inspection or Accreditation Survey – Part 1. Then, walk through each step of the practice of pharmacy such as data entry; drug utilization review; compounding; final association between the drug, the prescription, and the label (eg, the dispensing act); and patient counseling.

Drug Utilization Review

Express Pharma

MARCH 23, 2023

Pharmaceutical packaging has come a long way in recent years. The industry constantly innovates to provide the most reliable and efficient packaging solutions, from automated assembly lines to shrink-wrap and other state-of-the-art technologies. Different types of pharma packaging include blister packs, bottles, and capsules.

Packaging

FDA Law Blog: Biosimilars

SEPTEMBER 6, 2023

Food and Drug Administration – labeled an “Official Action Indicated” classification – is generally devastating for the facility, not least because it can stall FDA approval of applications to market drugs manufactured at the facility. By Douglas B. Farquhar — A drug manufacturer’s bad post-inspection grade from the U.S.

Packaging

Express Pharma

MARCH 23, 2023

Pharmaceutical packaging has come a long way in recent years. The industry constantly innovates to provide the most reliable and efficient packaging solutions, from automated assembly lines to shrink-wrap and other state-of-the-art technologies. Different types of pharma packaging include blister packs, bottles, and capsules.

Packaging

FDA Law Blog: Biosimilars

NOVEMBER 2, 2023

The guidance describes elements that would be required of VCS bodies for recognition of standards they adopt: openness (with meaningful opportunities to participate), balance (broad range of stakeholders), due process, an appeals process, and consensus.

Packaging

Putting Patients First Blog

JULY 10, 2023

The NHC encourages the FDA to develop a process for collecting and adding new examples to the guidance package as the opportunity arises.

Communication

Express Pharma

MAY 10, 2023

In the case of parenteral drugs, CCI aims to avoid adulteration of the drugs packaged in vials, syringes, and cartridges. Even though these types of packaging systems are sealed in a hermetic manner, there are still many risks to mitigate. Vials, cartridges, and syringes are often packaged one of two ways. micron filter.

Packaging

Express Pharma

JANUARY 4, 2024

They are continuing to invest heavily in the automation of manufacturing and packaging, improving productivity, operational cost efficiency, and labeling accuracy, proactively mitigating potential risks. The focus has shifted from manual and transactional processes to automation and strategic innovation.

Packaging

The Thyroid Pharmacist

JULY 29, 2022

I was inspired to write this blog after the September 2020 Cameron Peak fires in Colorado. 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.

Health and Personal Care Stores

FDA Law Blog: Biosimilars

JANUARY 3, 2024

Specifically, CVM ensures that animal drugs are safe and effective, properly made, and adequately labeled and packaged; food-producing animals only take drugs that would be safe for humans to consume; pet foods and additives are safe; and educates the public, monitors the market, and encourages development of new animal health products.

Packaging

GMPSOP

JULY 14, 2023

Equipment cleaning validation protocol was not discussed intensely in this article which was covered elsewhere in this blog. In other areas, such as in secondary packaging or in material storage areas, the product isn’t exposed to the environment, so there is a lower risk of contamination.

Documentation

RX Note

FEBRUARY 23, 2023

Introduction The purpose of this table of contents is to enable you to know clearly which topics are available in the blog, hence easing your learning process. Terazosin - Off-label use in ureteral stone(s) expulsion Topical Corticosteroids - Apply thinly on the skin using fingertip unit. Ancora imparo: I am still learning.

HIV Treatment and Prevention Agents

FDA Law Blog: Biosimilars

DECEMBER 14, 2023

As justification, the governors argued that state-regulated cannabis would require age verification, packaging and labeling standards, testing and warning symbols or statements, and allow for tracking products from seed to sale.

Controlled Substances

FDA Law Blog: Biosimilars

JANUARY 20, 2025

Gaulkin & Ritte van Laack Readers of this blog likely are familiar with the ongoing, often contentious battle over the labeling of plant-based foods (see, e.g., here , here , and here ). non-standardized foods), their labeling must bear the common or usual name of the food, if such a name exists. By Sophia R.

Labelling

FDA Law Blog: Biosimilars

JULY 10, 2025

Snow & Riëtte van Laack — Two southern states are taking bold steps to change the way they approach food labeling—and they’re not mincing words. Texas Goes BIG on Food Warnings Beginning on January 1, 2027, Texans may notice new warning labels on some food products sold in their fair state. By Charles D.

Labelling

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.

Packaging

The Nutrition Pharmacist

JUNE 3, 2025

In general, supplements on the ARTG ( look for an AUSTL or AUSTR on the label ) need to include ingredients at the right dose (based on evidence) to do the things they claim to do. This can be a little harder to decipher based on packaging and marketing alone. If you want a therapeutic outcome (e.g.

Labelling

RX Note

JUNE 20, 2025

page.tsx defines individual routes like / , /about , or /blog/[slug]. Dependencies - package.json Modern development thrives on code reuse through packages and modules. Instead of building everything from scratch, developers install high-quality, pre-tested packages. default limits, labels, category names).

Packaging

RX Note

JUNE 20, 2025

page.tsx defines individual routes like / , /about , or /blog/[slug]. Dependencies - package.json Modern development thrives on code reuse through packages and modules. Instead of building everything from scratch, developers install high-quality, pre-tested packages. default limits, labels, category names). behavior (e.g.

Packaging

Express Pharma

APRIL 25, 2025

Paying attention to details at every step, from labeling, packaging, and storage to transportation, ensures a supply chain where quality and standards are maintained. Industry standards have evolved to incorporate temperature-controlled packaging leveraging advanced technology.

Packaging