FDA Law Blog: Biosimilars

APRIL 2, 2024

In the first category, FDA asks Congress to amend the FDCA to require drug manufacturers to disclose full information about the name and quantity of inactive ingredients in product labeling and permit FDA to disclose to generic sponsors the names and amounts of such inactive ingredients.

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Labelling Biosimilars Drug Pricing Dosage 104

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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Labelling Packaging Documentation Dosage 52

Express Pharma

APRIL 6, 2023

This can include everything from product testing and labelling to marketing and advertising requirements. As a result, nutraceutical startups need to stay informed about the latest regulatory changes and requirements in the states where they do business. Failure to do so can lead to legal and financial consequences.

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Labelling Dosage Packaging Documentation 98

PharmaTech

JANUARY 16, 2023

The guidance provides examples of required and recommended information in the Dosage and Administration section.

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Labelling Dosage 40

pharmaphorum

AUGUST 11, 2022

These drugs have been rigorously tested by regulatory bodies around the world before they’re made available to ensure they work as labelled, but despite that, adverse events crop up. Looking at an individual’s genomic profile also provides an understanding of appropriate medication dosage. billion in the United States alone.

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FADIC

OCTOBER 20, 2023

People can follow the “Drug Facts Label” directions on OTC products for proper use. Pharmacists can provide patients with the necessary information to make proper selections when choosing OTC products. This personalized approach allows them to gather detailed information about a patient’s condition.

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Express Pharma

JUNE 2, 2023

Counterfeit drugs, intentionally mislabeled or misrepresented, often contain substandard or harmful ingredients, incorrect dosages, or no active ingredients at all. These systems enable real-time monitoring, accurate data capture, and seamless integration of information across various stakeholders, from manufacturers to healthcare providers.

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RX Note

NOVEMBER 12, 2024

It supports informed, evidence-based clinical decision-making, drug supply chain management and patient education. Features The new Micromedex mobile app provides unified access to all essential drug information from a single, comprehensive app. Hence, there would be no significant difference in the information offered.

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RX Note

MARCH 18, 2023

It is a quick reference for indication, dosage, availability and prescribing category. For drugs not available in MOHMF , a separate drug list (with specific indication and dosage information) should be created so that individual facility can activate the medicines into hospital formulary if needed.

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Hospitals Dosage Labelling 52

FADIC

OCTOBER 24, 2023

The application includes submitting clinical drug trial data and information about the manufacturing process. Drug manufacturers also have to submit details about how the drug works in the human body, guidelines for dosage, and information on safety and side effects. This information is included in the prescription.

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Health and Personal Care Stores Insurance Coverage and Processing Labelling Dosage 52

European Pharmaceutical Review

OCTOBER 5, 2022

Beyond the risk of accidental ingestion, there are also health requirements surrounding ingredient profiles and the safe administering of medicines, including dosages and product accessibility. Reaching for the renewable. Pharmaceutical packaging firms are currently researching bio-based and renewable materials.

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GMPSOP

AUGUST 11, 2024

Documentation : Keeping detailed records of orders, specifications, manufacturing processes, packaging, and labeling to ensure traceability and compliance. Packaging and labeling operations for investigational products are often complex and must meet specific requirements to ensure the integrity of clinical trials. Subscribe 6.

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Packaging Documentation Labelling Dosage 52

European Pharmaceutical Review

JUNE 4, 2024

The ADAPTA 50 capsule filler features innovative technical solutions to manage complex solid dosage forms such as product combination in hard gelatine capsules or powder micro-dosing for Dry Powder Inhalers. customers will have the opportunity to experience first hand various digital solutions aimed at reducing maintenance costs and downtime.

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Packaging Customer Service Labelling Dosage 95

FADIC

OCTOBER 20, 2023

Patient Counseling Points for Vitamins: Vitamin A: Advise patients to follow the recommended dosage, as excessive intake can lead to toxicity. Inform patients that Vitamin A is essential for healthy vision, immune function, and growth and development. It is found in animal products such as meat, fish, and dairy.

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RX Note

MARCH 10, 2023

The information is organised in following sequence (where appropriate). Uses and off-label use (with recommended dosage) Oral medication administration Advice to patients and Essential points, such as adverse drug reaction and role in therapy. However, always refer to the relevant sources of information when in doubt.

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Community Pharmacies Hospitals Dosage Labelling 52

The Thyroid Pharmacist

AUGUST 23, 2023

Please note: Some people may need to increase their dosage of thiamine from 600 mg per day. It looked at the effect of thiamine on patients with Crohn’s disease and ulcerative colitis, and found that effective dosages ranged from 600 mg to 1,500 per day, depending on individual body size. [7] Have you tried thiamine?

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RX Note

DECEMBER 16, 2023

Similarly, incomplete information about brand names can also lead to medication errors, such as "clopixol accuphase" and "clopixol depot". I did not identify any errors on medication label and the quantity prepared. This highlights the importance of double-checking unfamiliar dosages to prevent potentially serious medication errors.

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Labelling Dosage Medication Labelling Packaging 52

RX Note

JULY 13, 2023

During my hospital placement, I recalled a drug information pharmacist mentioning that although Therapeutic Guidelines is a national guideline, they do compare it against international guidelines such as UpToDate to develop hospital management guidelines.

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Express Pharma

MAY 22, 2023

As the experts at this round table also discussed the need for such a centralised body, Srivastava, who was part of a meeting held by the Nutraceutical Task Force, informed that the formation of a nutraceutical panel in the Ministry of Commerce to ensure a nutraceutical industry-specific agenda is underway.

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pharmacy mentor

SEPTEMBER 2, 2024

Clinical Decision Support Drug Interaction Checking : AI can provide real-time alerts for potential drug interactions , contraindications and allergies, assisting pharmacists in making informed decisions. Dosage Recommendations : AI tools such as Dosis can analyse patient-specific data (e.g.

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Customer Service Medication Therapy Management (MTM) Dosage Scheduling Appointments 52

RX Note

JUNE 3, 2023

However, the information such as indications, dosages, adverse reaction, contraindications, interactions, precautions and method of purchase, in FUKKM is continuously being updated throughout the year. Registered with Drug Control Authority and medicine is listed in MOHMF but off label use from Drug Control Authority.

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Adverse Reactions Dosage Hospitals Labelling 40

Pharmaceutical Technology

MAY 11, 2008

Europe is favouring 2D data matrix codes to encode information while the US is tending more towards RFID. In the US solid dosage forms are distributed as containers of tablets and these can only be coded on the container and not on a per-item basis. There are two kinds of new technology working towards coding each format of dispensing.

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Pharmaceutical Technology

JANUARY 6, 2023

At the centre of the case was Gilenya’s ‘405 patent, which details methods for treating relapsing multiple sclerosis with a specific dosage of the drug. Novartis argued that the early release of Entresto generics could cause labelling inconsistencies.

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GMPSOP

FEBRUARY 25, 2023

Finished product samples are drowned from packed products to check if the labels are applied correctly, batch number and expiry dates are correct and legible. You will also check printed labels that are affixed on primary containers display correct information (e.g., These are called primary packaging materials.

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Labelling Packaging Documentation Pharmaceutical Manufacturing 52

RX Note

JUNE 12, 2023

To ensure safe maintenance of thyroid hormone levels, authorities are adopting stricter potency specifications for L-T4, the most stringent of these being 95-105% of the labelled dose over the whole shelf-life. Storage DISCLAIMER: The following information is not intended as a practice update, but as an observation for discussion.

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GMPSOP

JUNE 9, 2024

Proper labeling and traceability are essential when it comes to reagents. All reagents, whether bought from suppliers or made in the lab, must have legible labels with their name, lot or batch number, and vendor information. Labels that identify divisions in reagents should enable us to locate the original source.

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Method Validation Documentation Health and Personal Care Stores Labelling 52

The Thyroid Pharmacist

AUGUST 18, 2023

Research has shown plasma concentrations of curcumin as low as 50 ng/mL after administration of dosages as high as 12 g/day. The dosage I used when working to detox my body of arsenic was 500 mg, three times per day. Headaches and nausea have been noted in a small number of people at dosages over 450 mg.

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ID Stewardship

JUNE 6, 2023

Patient Education and Adherence : AI chatbots or virtual assistants can be developed to provide patients with on-demand information about their medications, dosages, potential side effects, and adherence strategies. This empowers patients to make informed decisions and fosters better medication adherence.

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Insurance Coverage and Processing Prescription Filling Hospitals Medication Dispensing 52

RX Note

AUGUST 25, 2024

A quick question: Do you know the common dosage of St. About Herbs by Memorial Sloan Kettering Cancer Center - Offers evidence-based information on traditional and proven uses. Herb at a Glance by US National Center for Complementary and Integrative Health - Provides brief fact sheets with basic information about specific herbs.

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Diabetes Community Pharmacies Dosage Documentation 52

FDA Law Blog: Biosimilars

JUNE 16, 2023

Under Minnesota’s Prescription Drug Price Transparency Act , manufacturers must submit detailed pricing information for any generic prescription drug with a WAC of at least $100 for a 30-day supply or shorter course of treatment for which it increased the WAC by 50% or greater over the previous 12-month period.

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Drug Pricing Biosimilars Dosage Documentation 45

Fusion Pharmacy

JULY 2, 2023

You’ve probably noticed that some supplement labels have a long string of ingredients and others have just a few. With a quality supplement, your dosage may be smaller, and your body won’t have to filter through and clear out foreign ingredients. Not all manufacturers make a quality product.

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Quality Matters

JUNE 26, 2023

The same potential benefits can apply for so-called “complex generics” (CGx), which are generic drug products that have a complex active ingredient, formulation, dosage form, route of delivery, or are part of a drug/device combination.

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Viseven

APRIL 11, 2023

By mapping out the content, brands can identify gaps in their content offerings and opportunities for new content that can better engage and inform their audience. Therefore, companies in pharma must ensure that their content complies with regulations while providing valuable information to their target audience.

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RX Note

MARCH 23, 2023

When no stability information is available, pharmacist may dispense oral tablet or capsule and direct the caregiver to freshly prepare just prior to administration. Product should be labelled clearly and stored as recommended within the formula. X-Temp Oral Suspension System Orange flavoured, sweetened, sugar-free vehicle.

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Compounding Health and Personal Care Stores Hospitals Dosage 52

The Thyroid Pharmacist

JUNE 30, 2023

I have personally seen this medication change people’s lives and wanted to share some more information on it, in case you have hit a plateau in your healing journey. Dr. Bernard Bihari is credited with making these discoveries about using naltrexone off-label, at lower doses. LDN is truly an intriguing drug.

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Pharma in Brief

JANUARY 17, 2021

The Court rejected Pharmascience’s argument that the skilled person could have easily prescribed Copaxone ® 20 mg for the claimed use, though off-label. The 802 Patent also discloses the reasoning for the frequency and strength of its dosage, and points to other studies and trials for evidence of safety and efficacy. No enablement.

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GMPSOP

FEBRUARY 10, 2024

GMP/GLP and PPE training are applied to all employees, contractors and casual staff working in a GMP environment, including manufacturing, packaging, labelling, distribution, QA, QC, development, validation, engineering, IT staff and anyone whose activities could affect product quality. – Carry out agreed development plans.

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Health and Personal Care Stores Documentation Packaging Compounding 52