Pharmacy Times

JUNE 23, 2025

Additionally, ANDA submissions should extrapolate the RLD safety and effectiveness data for drugs with the same active ingredients, dosage forms, strengths, routes, and labeling. In the 505(j) ANDA approval pathway, on the other hand, submissions can be multisource generic drugs; however, this pathway requires bioequivalence to the RLD.

FDA

Pharmacy Times

JUNE 16, 2025

1 As part of another action designed to reduce drug costs, Newsom also announced the expansion of CalRx, the state’s initiative to produce generic drugs under the state’s own label, giving CalRx the authority to purchase brand-name drugs. Furthermore, DMHC would have clear authority to enforce rules and penalize violations. Koseff A, Hwang K.

Compounding Pharmacies

Pharmacy Times

JUNE 20, 2025

There are too many drug approvals, label updates, and new data published for even the most skilled and experienced oncology pharmacist to keep up with, let alone those still building their baseline knowledge. Oncology pharmacy practice changes at a rapid pace. Fifteen years ago, pharmacists could learn oncology on the job. LinkedIn Learning.

Compounding

Pharma Marketing Network

MARCH 8, 2025

No unapproved drug claims All claims must be backed by clinical research and FDA-approved labeling. download a whitepaper, request a sample). FDA and HIPAA Compliance in PPC Fair balance requirements Ads must include benefits and risks equally. Key Metrics to Monitor Click-Through Rate (CTR): Indicates how engaging the ad copy is.

HIPAA

Pharmaceutical Commerce

JUNE 17, 2025

This includes requirements for drug data storage and the maintenance of interoperable systems for sharing data, along with requirements for the data that must be stored on treatment labels. Together, these requirements create a foundation of RWD that stakeholders can leverage to improve supply chain operations and safety. References 1.

Health and Personal Care Stores

The Checkup by Singlecare

APRIL 18, 2025

For Dose 2 (pouches A and B), you will follow the same steps that you did with the Pouch labeled Dose 1, with Pouch A and Pouch B being taken together. Download it and show it to your pharmacist when picking up your prescription to see how much you can save. There are a couple of ways to make Plenvu more palatable.

Insurance

Pharmacy Times

JUNE 20, 2025

In general, choosing a product that has broad spectrum on the label, covering both UV-A and UV-B rays and containing 20% zinc oxide, for her children will be optimal, especially for more sensitive areas of the skin. Whereas SPF 15 blocks approximately 93% of UV-B rays, SPF 30 and SPF 50 increase coverage slightly (97% and 98%, respectively).

Compounding Pharmacies

OctariusRx

JUNE 2, 2025

Use warning labels for both Confused Drug Names and High-Alert medications. If the labels on the shelf are bent, frayed or in any way hard to read, replace them with fresh and clear versions. Safe injection practices: Every year, demonstrating safe injection practices is near the top of the list of most common deficiencies.

Compounding

Pharmaceutical Technology

JUNE 30, 2025

The agency said that safety information can be adequately conveyed using drug product labelling. Please check your inbox to download the Whitepaper. How will RFK Jr’s American dream for vaccines play out? This includes a boxed warning for the risks of CRS and neurological toxicities. You will receive an email shortly.

FDA

The Checkup by Singlecare

JULY 2, 2025

For example, you may be able to get coverage for liraglutide (generic Victoza ) off-label for weight loss. Once you choose where to have your healthcare provider send your prescription, you can print or download a Saxenda coupon to show your pharmacist and save close to $600 per month. The post Does United Healthcare cover Saxenda?

Insurance

Pharmaceutical Technology

JUNE 30, 2025

Download to learn about the causes of contamination and how to adapt your parenteral packaging – one potential source – to minimise the risk. Please check your inbox to download the Whitepaper. To learn more about supply chain strategies for safeguarded pharmaceutical production, download the whitepaper below. [i]

Health and Personal Care Stores

Pharmaceutical Technology

JULY 22, 2025

“It is important for the patients we serve that Sarepta maintains a productive and positive working relationship with FDA, and it became obvious that maintaining that productive working relationship required this temporary suspension while we address any questions that FDA may have and complete the Elevidys label supplement process.”

FDA

Pharmaceutical Technology

JULY 16, 2025

This can be achieved by taking responsibility for warehousing, packing and labelling, order management, distribution, freight audit, and transportation trend management of pharma materials. To learn more about global 3PL delivered by ICS and Alloga, download the free whitepaper below. Please check your inbox to download the Whitepaper.

Pharmaceutical Companies

Pharmaceutical Technology

JUNE 16, 2025

By GlobalData Learn more about Strategic Intelligence Corwin added that Elevidys’s label will likely be updated to reflect the risk of ALF. Please check your inbox to download the Whitepaper. Don’t let policy changes catch you off guard. Stay proactive with real-time data and expert analysis. You will receive an email shortly.

Communication

Pharmaceutical Technology

JUNE 13, 2025

Vaccines under political pressure Whilst the label expansion reflects an easing in regulatory tension surrounding mRNA vaccines under the Trump administration, FDA approval does not automatically mean shots enter national immunisation schedules. Please check your inbox to download the Whitepaper. You will receive an email shortly.

Vaccines

The Checkup by Singlecare

JUNE 24, 2025

There are anecdotal reports that off-label use could help alleviate pain and infertility symptoms, but more research is needed to understand its effects. There is a strong hope that this off-label use will lead to an improved quality of life for this important, and oftentimes underserved, group of women.”

Insurance Coverage

Pharmaceutical Technology

JULY 17, 2025

July 17, 2025 Share Copy Link Share on X Share on Linkedin Share on Facebook The announcement included updates on Elevidys’ label changes for Duchenne muscular dystrophy treatment. It also announced an update regarding its Elevidys label changes for Duchenne muscular dystrophy (DMD) treatment. Credit: luchschenF/Shutterstock.com.

Labelling

Pharma Times

JUNE 11, 2025

Find jobs Download our apps Go to the App Store or Google Play and search for ‘PharmaTimes’ to download our free app. The results, presented at EULAR 2025, show sustained inflammation control and significant long-term improvements in symptom relief and physical function. This field is required.

Labelling

Pharmaceutical Technology

APRIL 11, 2023

This label expansion makes Orkambi the only disease-modifying CF medication available to patients of this age in Canada. This label expansion follows a similar label change in the US in September 2022. Health Canada is granting this new label expansion based on recent results from a Phase III study.

Labelling

Pharmaceutical Technology

MARCH 25, 2024

Download our extensive, free list of the leading pharmaceutical packaging companies and labelling machine manufacturers today.

Packaging

Pharmaceutical Technology

JUNE 19, 2023

Issues with regulatory requirements and documentation can also cause significant delays, while any inaccuracies in translations on labelling can mean that dosage and storage information is not correctly understood or followed. And accurate labelling and translation are critical for this sector.

Labelling

Pharma Marketing Network

APRIL 15, 2021

Download this infographic and learn which 6 digital tools are at the center of digitalization and how the will influence the future of Pharma marketing in 2021 and beyond. Company Email *.

Labelling

NF2 BioSolutions

JANUARY 4, 2023

Print our cake labels, bunting and flyers to make your event a great success. Cake Sale Resources: Cake Sale Poster: Click here to download! 5K Challenge Resources: 5K Challenge Poster: Click here to download! You can set up a personal fundraiser on Peoples fundraising or simply choose the existing NBS UK fundraiser.

Labelling

pharmaphorum

JUNE 8, 2022

The new tool works as a component of Apple’s Health app and will let users add drugs or other health products like vitamins and supplements to a personal list – either by scanning a label or finding the product in a directory – and create custom schedules for them.

Documentation

Pharmaceutical Technology

MAY 19, 2023

MT-101 will be evaluated in the first-in-human, multicentre, open-label, multiple ascending dose Phase I/II IMAGINE trial to treat refractory or relapsed peripheral T cell lymphoma (PTCL) and cutaneous T cell lymphoma (CTCL) patients.

Labelling

The Checkup by Singlecare

JANUARY 18, 2023

Off-label weight-loss medications. Sometimes, your provider may recommend another type of medication for off-label use. Off-label prescribing is when a drug is prescribed for a use that is not FDA-approved. Although Mounjaro is currently prescribed off label , the medication may be approved for weight loss by the FDA soon.

Insurance

Pharmaceutical Technology

APRIL 6, 2023

The PRIME scheme designation was granted by the EMA based on positive results obtained from the ongoing Phase IIb randomised, open-label KEYNOTE-942/mRNA-4157-P201 trial that enrolled 157 patients with stage III/IV melanoma.

Vaccines

Pharmaceutical Technology

JANUARY 24, 2023

The multi-centre, open-label, single-arm clinical trial has been designed to evaluate the efficacy, tolerability, and safety of a single dose of NGN-401 delivered using a one-time ICV procedure. Neurogene stated that the FDA IND clearance allows it to commence a Phase II/II trial of NGN-401 in female paediatric Rett syndrome patients.

FDA

Pharmaceutical Technology

NOVEMBER 30, 2022

weight reduction in obese individuals, as per its label. Furthermore, in order to make up for shortages Novo Nordisk’s Ozempic, a version of semaglutide that is approved to treat type 2 diabetes, was used off-label for obese patients. Download the full report to understand what to expect and how to align your strategies for success.

Labelling

Pharmaceutical Technology

NOVEMBER 30, 2022

weight reduction in obese individuals, as per its label. Furthermore, in order to make up for shortages Novo Nordisk’s Ozempic, a version of semaglutide that is approved to treat type 2 diabetes, was used off-label for obese patients. Download the full report to understand what to expect and how to align your strategies for success.

Labelling

Pharmaceutical Technology

JUNE 7, 2023

AstraZeneca will now proceed with regulatory filings in the US and EU to convert to full label approval, with full results from the trial to be presented at a forthcoming medical meeting. Download the full report to understand what to expect and how to align your strategies for success. Evaluate the effects of COVID-19 on the sector.

Labelling

Pharma Marketing Network

AUGUST 2, 2021

Download our EHSX one-pager to learn more! EHSx can connect your brand with your target audiences on over 4,000 quality whitelist healthcare publishers, and 10,000 pharma-safe, non-endemic properties.

Labelling

Pharmaceutical Technology

SEPTEMBER 20, 2022

Clinical packaging and labelling follow stringently controlled procedures and high-standard quality control measures to assure the safety and functionality of investigational medicinal products, during their storage, distribution, and use. Clinical trial packaging and labelling solutions. Trends in clinical packaging.

Packaging

BioPharm

MARCH 15, 2023

Based on Bio-Layer Interferometry (BLI), it enables real-time, label-free analysis for the determination of kinetics, affinity, and antibody/protein quantitation. It enables a huge variety of applications performed at various stages of biologics development — from early selection to validation to manufacturing.

Labelling

Pharmaceutical Technology

DECEMBER 4, 2022

Humira is indicated for 10 adult and pediatric conditions, including Crohn’s disease, rheumatoid arthritis, and ulcerative colitis, as per its label. Download the full report to understand what to expect and how to align your strategies for success. Please check your email to download the Report. By GlobalData. United Kingdom.

Labelling

Pharmaceutical Technology

MAY 3, 2023

With this recent news, San Francisco-based Tenaya is initiating a multi-centre, open-label Phase Ib clinical trial for the drug. Download the full report to understand what to expect and how to align your strategies for success. Please check your email to download the Report. Evaluate the effects of COVID-19 on the sector.

Mayo Clinic

Pharmaceutical Technology

JANUARY 6, 2023

Novartis argued that the early release of Entresto generics could cause labelling inconsistencies. Download the full report to understand what to expect and how to align your strategies for success. Please check your email to download the Report. Evaluate the effects of COVID-19 on the sector. By GlobalData. United Kingdom.

Documentation