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.

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Pharmaceutical Technology

APRIL 26, 2023

Packaging plays a critical part in the pharmaceuticals and medical devices industries and is developed with its own set of security standards for the safety of consumers. The role of primary packaging has extended beyond the primary objectives of sterility, physical and chemical protection, and security.

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Packaging Documentation Communication Labelling 52

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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Labelling Communication Packaging 52

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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Packaging Labelling 52

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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Packaging Labelling Documentation Pharmaceutical Companies 40

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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Labelling Packaging 59

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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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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FDA Documentation Method Validation Packaging 98

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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Compounding Labelling Packaging Hospitals 130

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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Packaging Customer Service Labelling Dosage 95

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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Packaging Compounding Communication Labelling 98

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.

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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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Labelling FDA Packaging 40

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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Packaging Labelling Communication Pharmaceutical Companies 52

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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Packaging Labelling Hospitals 98

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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Packaging Labelling FDA Documentation 45

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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Chemotherapy Dosage Packaging Hospitals 105

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.

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Documentation Packaging Labelling Pharmaceutical Companies 52

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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FDA Labelling Packaging Documentation 59

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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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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Packaging Labelling Communication Pharmaceutical Companies 40

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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FDA Packaging Labelling Dosage 52

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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Dosage Labelling Packaging Immunization 96

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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Packaging Labelling 52

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. .

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Customer Service Labelling Packaging 52

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.

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Adverse Reactions Dosage HIPAA Community Pharmacies 74

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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Immunization Labelling Dosage Medication Labelling 102

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.

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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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Patient Care Labelling Hospitals Adverse Reactions 52

The FDA Law Blog

OCTOBER 5, 2022

In 2015, FDA issued a Warning Letter to Kind LLC because, among other things, the company labeled products as healthy whereas these products provided more saturated fat per serving than permitted by the regulatory definition. This information is not included in the proposed codified language for the regulation.

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FDA Labelling Packaging Documentation 52

Pharmaceutical Technology

MAY 11, 2008

Data has long been incorporated into drug packaging to accomplish these goals, but only to a partial degree with embossed lot numbers, expiry dates and even Braille identification in addition to linear bar codes. Europe is favouring 2D data matrix codes to encode information while the US is tending more towards RFID.

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Packaging Labelling Pharmaceutical Companies Pharmaceutical Companies 40

The Checkup by Singlecare

JULY 17, 2023

Docusate package instructions generally advise taking the laxative no longer than a week. A 238-gram package of MiraLAX powder costs about $17. This page also includes additional savings and drug information in the FAQs section at the bottom. For most people, taking docusate should not be a long-term daily habit.

Insurance 52

Insurance Packaging Dosage Labelling 52

pharmaphorum

JANUARY 30, 2023

The group is continuously gathering information from Member States and industry associations to identify signals of availability issues as early as possible.” Looking to the long-term However, despite the issue being exacerbated by geopolitical factors, the challenge is a broad one that requires a long-term strategy to navigate.

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Generic Medicine Packaging FDA Labelling 104

The FDA Law Blog

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.

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Labelling FDA Packaging 45

Pharmaceutical Technology

JANUARY 15, 2023

While Catalent Inc and PCI Pharma Services are in charge of the solid dose and packaging of Lupkynis, Lonza is manufacturing the small molecule API. In the same month, the EMA expanded the label of Gilead Sciences’ Biktarvy (bictegravir/emtricitabine/tenofovir alafenamide) to include its use for virologically suppressed HIV-positive children.

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Labelling Packaging FDA Communication 52

pharmaphorum

OCTOBER 27, 2022

Information on social media and digital channels should be kept up to date and date stamped, with the date posted or last updated. The post New IFPMA and EFPIA guidance on use of social media by the pharmaceutical industry appeared first on.

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Communication Packaging Documentation Pharmaceutical Companies 98

The Checkup by Singlecare

DECEMBER 26, 2023

You can also find information about how many milligrams of potassium are in packaged foods by reading their dietary guidelines on food labels. Broken down by fruits, vegetables, meats, nuts, and legumes, you can pick and choose your favorite foods so you can easily get enough potassium.

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