FDA Proposes Front-of-Package Nutrition Label for Most Packaged Foods
Pharmacy Times
JANUARY 17, 2025
If finalized, the requirement would include readily available nutrition information, including saturated fat, sodium, and added sugar content.
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Guidance for medicine packaging under Windsor Framework
European Pharmaceutical Review
AUGUST 30, 2023
The agreement stipulates that certain conditions must be met in the labelling and packaging of these medicinal products. After this date: Under the framework, medicines can have the same packaging and labelling across the UK. UK packaging must carry a clearly legible ‘UK only’ label to be allowed onto the UK market.
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Ampoules packaging market forecast to 2033
European Pharmaceutical Review
MAY 28, 2024
A report by The Brainy Insights has predicted that the ampoules packaging market will value $9.83 This is expected to be largely driven by increasing demand for this packaging type. Considering material type, glass ampoule packaging was found to hold a market share of around 77 percent in 2023, in comparison to plastic.
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Sustainable pharma packaging: breaking down the barriers to adoption
European Pharmaceutical Review
OCTOBER 5, 2022
For most consumers, product packaging represents their first impression of a brand and its sustainability credentials. But how is this push shaping the pharma packaging market and what are the key changes we can expect to see? For many, aesthetic appeal and user experience top the list of priorities when it comes to packaging design.
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ePI rollout backed in new paper by pharmaceutical bodies
European Pharmaceutical Review
JANUARY 9, 2025
Three industry bodies have produced a joint position paper highlighting recommendations for adopting a harmonised implementation of electronic Product Information (ePI) leaflets. It will also enable more patient-centric and accessible content by providing the most up-to-date information.
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PreSTAR: a New Template for Pre Submissions and 513(g) Requests for Information
The FDA Law Blog
JUNE 26, 2024
Lenz, Principal Medical Device Regulation Expert — FDA recently released a new eSTAR template for device pre-submissions and 513(g) Requests for Information, referred to as PreSTAR. A 513(g) Request for Information is a means of obtaining FDA’s views about the classification and regulatory requirements for a particular device.
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Can holograms help in the frontline fight against pharmaceutical counterfeiting?
European Pharmaceutical Review
NOVEMBER 24, 2022
One area in which the problem can be tackled effectively is product packaging. With predictions that the global market for anticounterfeiting packaging is set to reach almost $250 billion by 2026, growth in authentication and anti-tamper devices such as holograms appear to have a healthy future.”
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Medication Adherence and the Importance of Packaging
Lifewell Rx Pharmacy
JUNE 9, 2021
For example, packaging plays a vital role in promoting medication adherence. A retail pharmacy may use blister packs , Dispill®, and other types of special packages to organize prescriptions and label medications according to dosage and time of intake. b>Medication Information. Drug Quality.
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RxSource optimizes clinical labeling process with PRISYM 360 cloud-based solution
pharmaphorum
JANUARY 28, 2021
For PRISYM ID client RxSource , a Global Clinical Trial Supplies Specialist, it means being ready to partner with sponsor companies to get everything set up for a clinical trial within a week, including packaging and labeling. This was an incredibly fast turnaround for what could easily have been a long and arduous onboarding process.
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Leading clinical packaging companies in contract marketing
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. Finding the best clinical trial packaging services providers.
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Smart pharmaceutical and healthcare labels: Lets trace medicines from its origin
Roots Analysis
MARCH 8, 2023
Traditionally, text and images were printed on pharmaceutical products to convey important information. In recent years, the use of smart labels allows the developer to convey a greater amount of information about the product to the consumers, without the need for additional packaging space.
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Develop and execute a winning drug launch strategy with an experienced contract packager
Pharmaceutical Technology
JUNE 14, 2023
Navigating the complexities of pharma and biotech packaging services can be difficult. With the growing number of complex therapies that require specialized packaging and handling requirements, selecting the right contract packaging organization (CPO) involves evaluating what services and additional benefits they can bring to your business.
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How to decode prescription labels for your patients
The Checkup by Singlecare
JANUARY 26, 2023
If you’ve worked in a community pharmacy, you’ve likely had the same frustrating conversations about prescription labels over and over. Due to variability in health literacy, studies show that Americans’ level of understanding of prescription label instructions ranges from 53% to 89%.
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Leading commercial packaging companies in contract marketing
Pharmaceutical Technology
SEPTEMBER 15, 2022
Packaging plays a vital role in maintaining the quality, safety, user-friendliness and marketability of drugs and other pharmaceutical products. Finding the best commercial packaging suppliers in contract marketing. Pharmaceutical packaging formats and materials. Pharmaceutical packaging formats and materials.
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Sustainable Pharmaceutical Packaging Market: The Need, Advantages and Drivers
Roots Analysis
AUGUST 14, 2024
Packaging is the process of enclosing a product in a container in order to protect and store it. In the pharmaceutical industry, packaging plays a crucial role in ensuring the strength and integrity of a product. Further, the type of raw material utilized for packaging highly depends on the type of product / drug to be enclosed.
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BE labeling Rule Challenge Largely Fails but Court Takes Issue with Electronic and Text Message Disclosure Options
The FDA Law Blog
SEPTEMBER 29, 2022
As readers may recall, the current regulation provides for four options for a disclosure statement, i.e., text disclosure, symbol disclosure, electronic disclosure (QR code with a phone number for further information), and a text message disclosure.
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FDA guidance highlights E&L considerations for ophthalmic drug products
European Pharmaceutical Review
JANUARY 25, 2024
Therefore, extractables and leachables assessment should consider the packaging components of the CCS, including the labelling. However, according to the FDA, this is “less of a concern” for products, such as biological products, that are packaged in glass containers.
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5 Instances Of Challenging Antibiotic Workflows
IDStewardship
OCTOBER 14, 2024
Read all about this in the product label here. More information on ganciclovir in the label here. The process is detailed in the package insert here. Also fun fact, IV SMX/TMP does not require refrigeration once mixed, so it gets a “DO NOT REFRIGERATE” sticker, at least that is more convenient.
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The IMA Group at ACHEMA 2024 : All-In-One solutions for the pharmaceutical sector
European Pharmaceutical Review
JUNE 4, 2024
Solutions include washers, depyrogenating tunnels, liquid and powder filling and closing machines for vials, ampoules and Ready-To-Use (RTU), freeze dryers and relevant automatic loaders/unloaders, isolation technologies, labellers for vials and cartons and ancillary equipment.
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EU antibiotic shortages being monitored by MSSG
European Pharmaceutical Review
JANUARY 23, 2023
Through EMA’s engagement with its stakeholders, the Medicines Shortages Steering Group has received up-to-date information from community pharmacists on the situation in pharmacies across the EU. Based on current information from companies and stakeholders, it is expected that the situation will improve in the coming months.
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Shanghai ISPE Pharmaceutical Information Company holds 2022 China Pharmaceutical Supply Chain Summit
ISPE
MARCH 28, 2023
Thanks to the clinical supply chain service companies' years of industry development and operation, there are new developments in global supply chain layout, ultra-low temperature storage and distribution management breakthroughs, and growing packaging and labeling capabilities.
FDA Denies Vanda’s Citizen Petitions Regarding the Need for Braille Labeling for Tasimelteon Generics
The FDA Law Blog
AUGUST 17, 2023
Vanda requested that FDA revoke the approval of Apotex’s and Teva’s generic versions of Hetlioz on the grounds that the generic tasimelteon products did not meet the statutory “same labeling” requirement for generic drugs found in 21 U.S.C. § Vanda’s Hetlioz was, in fact, the first FDA-approved drug product to include braille labeling.
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Navigating Regulatory Challenges in Pharma Marketing: Best Practices
Pharma Marketing Network
AUGUST 9, 2023
Stay Informed and Updated Regulations in the pharmaceutical industry are constantly evolving. Ensure that all marketing materials, including advertisements, websites, and social media content, provide clear and accurate information about your products. Keep thorough records of approvals for future reference.
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EMA launches medicines supply support measures as part of wider EC initiative
Hospital Pharmacy Europe
OCTOBER 30, 2023
The voluntary solidarity mechanism , which is based on an informal setup during Covid-19, will enable any Member State that is facing a critical shortage and has already notified the EMA to request assistance from other Member States, which will then be able to support by redistributing medicines from its own available stock.
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What is Special about September 24, 2023 for the UDI System?
The FDA Law Blog
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. In addition, the final rule requires the submission of product information to the Global Unique Device Identification Data (GUDID).
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How long does Zofran take to work?
The Checkup by Singlecare
JUNE 17, 2024
It’s also can be used off-label to treat morning sickness during pregnancy. To avoid potential complications, it’s essential to inform your healthcare provider about any other medications you are taking. The blister packs did not adhere to federal packaging requirements.
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Leading pharmaceutical wholesalers
Pharmaceutical Technology
SEPTEMBER 5, 2022
The document contains detailed information on the suppliers and their product offerings, alongside contact details to aid your purchasing or hiring decision. Quality in terms of number of defective items, packaging and labelling, quality management system certification, research, development, and innovation.
FDA Issues Long-Awaited QMSR Final Rule
The FDA Law Blog
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.”
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Mastering Responses to FDA 510(k) AI Letters: A Strategic Approach
The FDA Law Blog
JULY 10, 2023
After a firm submits a 510(k) to FDA, FDA will request still more information after a first-pass review. According to the 2 nd Quarter FY2023 MDUFA V Performance Report , FDA issued a request for additional information (AI request) on the first FDA review cycle for 63% to 68% of 510(k)s submitted in FY2018 to FY2022.
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Can you give babies and toddlers Benadryl?
The Checkup by Singlecare
OCTOBER 9, 2023
If you’ve ever wondered if Benadryl is appropriate for babies, read on to learn about safety information for children, including dosage guidelines and side effects. If your healthcare provider gives you the go-ahead to give your child Benadryl , make sure to follow the instructions or the package directions exactly. 17 to 21 lbs.
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Navigating Regulatory Challenges in Pharma Marketing: Best Practices
Pharma Marketing Network
AUGUST 9, 2023
Stay Informed and Updated Regulations in the pharmaceutical industry are constantly evolving. Ensure that all marketing materials, including advertisements, websites, and social media content, provide clear and accurate information about your products. Keep thorough records of approvals for future reference.
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How much does semaglutide cost per month?
The Checkup by Singlecare
MARCH 10, 2025
If your healthcare provider prescribes Ozempic for weight management, which is an off-label use, insurance isnt as likely to cover it. Restrictions on off-label use: Insurance plans may not cover a medication prescribed off-label , that is, if its not prescribed for its FDA-approved use. affected by a shortage).
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FDA Draft Guidance: Everything You May Want to Know about OMUFA Fees
The FDA Law Blog
NOVEMBER 14, 2022
The draft guidance provides information regarding various aspects of the OMUFA program under sections 744L and 744M of the FDC Act, as added by the CARES Act. Delinquent entities will receive an invoice from FDA detailing information on the user fee incurred, the due date, and the payment instructions. Livornese — Early Nov.
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How long does it take for Zyrtec to work in dogs?
The Checkup by Singlecare
AUGUST 8, 2024
She also explains that “Zyrtec’s use for dogs is ‘ off-label.'” Check the drug’s packaging and label carefully before giving it to your pet. But it’s best to play it safe and inform the veterinarian about any medications or supplements the dog is taking. How quickly does Zyrtec work in dogs?
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Anti-Counterfeiting Technologies in Healthcare
Roots Analysis
MARCH 1, 2024
Examples of such technologies include DNA Taggants (a unique DNA tag used in the product / packaging that can be scanned using a designated instrument / equipment), invisible printing technologies, digital watermark technologies and hidden markers / print technologies. Such technologies have been shown to have highly secured features.
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PRIYSM ID boosts customer service offer with new customer experience team
pharmaphorum
JULY 13, 2021
The regulated content and labeling software firm has made three new customer-facing appointments and created a brand-new Customer Experience Team to provide enhanced, end-to-end customer support for medical device and clinical trial organizations. For more information:?? . Andrew Baud, Distil. www.prisymid.com. .
How AI can help pharmacists
The Checkup by Singlecare
JULY 17, 2024
Robotic dispensing systems help prepare prescriptions by packaging and labeling medications to improve efficiency. Pharmacists can use this information to make interventions that can reduce adverse reactions and medication errors, which are th e most common and preventable causes of patient harm.
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?!), For more information on fluoride and other strategies to minimize your exposure and encourage detoxification of fluoride specifically, check out my article on fluoride.
Can you drink on Mucinex?
The Checkup by Singlecare
JANUARY 4, 2024
Always follow the directions on the packaging or consult a healthcare professional if you have concerns about the appropriate dosage. In addition, the FDA label for the nighttime forms of Mucinex containing acetaminophen recommends avoiding three or more drinks per day.
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Pharmacovigilance deep dive: risk minimisation measures
European Pharmaceutical Review
SEPTEMBER 2, 2022
Jouaville: A recent review, which evaluated the sampling methodologies used in RMM effectiveness studies , showed that a minority of these studies provided supporting evidence to inform the theoretical framework for the sampling methodology. Available from: [link]. US Food and Drug Administration.
Prednisone for gout: Dosage, safety, and more
The Checkup by Singlecare
JULY 11, 2024
The drug’s label recommends doses of 5–60 mg per day. Not everyone will experience them, but according to information from the U.S. So people with gout should avoid high fructose corn syrup, packaged foods, processed foods—anything that comes from a package.”
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Penicillin allergy delabelling: A multidisciplinary approach for improved patient care
Hospital Pharmacy Europe
MAY 22, 2024
In developed countries, between five and 15% patients carry a penicillin allergy label , and patients receive a penicillin allergy label by their third birthday in approximately 75% of cases. However, a large body of evidence suggests upwards of 90% of patients with a penicillin allergy label are not truly allergic.
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Shining a light on Raman for microbiological analysis
European Pharmaceutical Review
FEBRUARY 23, 2023
1 The characteristics of these vibrations provide a ‘molecular fingerprint’ which can be used for identification and counting purposes; in particular, with biomolecules, large sets of information are provided by the vibrational and rotational spectra of different biological molecules. eds) Practical Raman Spectroscopy. link] Huang WE, et al.
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Oral medication for eczema: Types, benefits & side effects
The Checkup by Singlecare
MARCH 22, 2024
Immunosuppressants are not approved by the Food and Drug Administration (FDA) specifically to treat eczema, so their use in eczema is considered off-label. This warning can be found in the prescribing information and on the package insert for each drug. In moderate-to-severe eczema cases, an oral medication may be required.
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