FDA Law Blog: Biosimilars

JULY 22, 2024

Claud will be speaking at the conference in a session titled “Crafting Your Safety Blueprint for Adverse Events and Recalls under MoCRA.” s John W.M. s John W.M. You can register for the conference here. FDA Law Blog readers receive a 10% discount off the tuition fee (promo code D10-999-FDA25 ).

Packaging 57

Packaging Labelling 57

Safe Biologics

NOVEMBER 12, 2023

6 would prevent the HHS Secretary from requiring a switching study as part of the data package to receive the interchangeable designation. The event will convene patients, providers, policymakers and advocates to discuss a number of topics impacting the health care space and will be held at the Mayflower Hotel in Washington D.C.

Biosimilars 130

Biosimilars Drug Pricing Packaging Labelling 130

GMPSOP

APRIL 3, 2024

A pharmaceutical warehouse is responsible for receiving, storing, and releasing incoming goods (including labeling and packaging) and distributing finished products. These regulations recognize that product quality can be significantly impacted if manufacturing and packaging have taken place.

Labelling 52

Labelling Packaging Documentation Inventory Control 52

European Pharmaceutical Review

JANUARY 23, 2023

This has been exacerbated by geopolitical events such as war, the energy crisis and high inflation rates. A recent surge in respiratory infections has led to an increase in demand for antibiotics such as amoxicillin (alone and in combination with clavulanic acid), especially as paediatric formulations.

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Packaging Compounding Labelling Communication 98

Eye on FDA

AUGUST 22, 2023

The Untitled Letter posted this week involved an oral birth control pill which has a specific of contraindications contained in the label as well as a list of warnings and precautions and of the most common adverse events. The communications vehicle in question was a social media sponsored posting.

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Communication Packaging Labelling 68

LifeProNow

MARCH 10, 2023

million in investments in food safety and nutrition modernization, including food labeling and animal food safety oversight. To complement the funding requests, the agency’s budget proposal also includes a package of legislative proposals designed to bolster the FDA’s authorities to further its mission to protect and promote public health.

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Labelling Packaging Controlled Substances 130

GMPSOP

FEBRUARY 25, 2023

Starting materials are processed, sampled, tested, packaged, and released before the finished products are stacked on pharmacy shelves. Sampling is carried out on intermediate processed materials and tested to ensure those are formulated correctly, free from contamination and qualified for filling and packaging. as their visual aids.

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Labelling Packaging Documentation Pharmaceutical Manufacturing 52

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.

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Labelling Packaging 44

GMPSOP

AUGUST 28, 2023

Raw materials must be inspected to confirm that the containers are intact, have been provided according to the paperwork, and have labels affixed on them identifying the raw material name, batch number, and expiry date. For example, materials with Hold, Quarantine, or Rejected labels must be kept in a quarantine location.

Health and Personal Care Stores 52

Health and Personal Care Stores Labelling Packaging Documentation 52

Safe Biologics

DECEMBER 6, 2023

REMINDER: FDA Draft Guidance Would Remove Interchangeability Statement from Interchangeable Biosimilars Comments Due November 17th On September 15th, the Food and Drug Administration (FDA) released draft guidance removing the interchangeability statement from the product label/package insert. ASBM surveys of U.S. However, S.6

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Biosimilars Packaging Labelling Drug Development 130

Quality Matters

AUGUST 3, 2023

They comprise interconnected webs of local and global ingredient suppliers, manufacturers, packagers, distributors, providers, and regulators. active ingredients, excipients, other raw materials) Packaging materials (e.g., ampules, bottles, labels, cartons, shipping containers, desiccants) Services (e.g.,

Packaging 52

Packaging Compounding Pharmacies Pharmaceutical Manufacturing Documentation 52

RX Note

OCTOBER 5, 2023

Medication Error The term "medication error" is used to describe any preventable event that may cause or lead to inappropriate medication use or patient harm while the medication is in the control of the healthcare professional, patient or consumer. Use Tall Man lettering Use additional warning labels for LASA medicines.

Health and Personal Care Stores 52

Health and Personal Care Stores Labelling Packaging Compounding 52

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.

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Adverse Reactions Packaging Documentation Dosage 89

RX Note

DECEMBER 16, 2023

Introduction Medication error is any preventable event that may harm patient. I did not identify any errors on medication label and the quantity prepared. Also, similar packaging design across medication strengths can lead to inadvertent selection errors, potentially impacting patient safety. Sertraline 100 mg OD.

Labelling 52

Labelling Dosage Medication Labelling Packaging 52

pharmaphorum

AUGUST 19, 2020

Reggie Foster , Senior Director Labelling, Logistics & Packaging, Kite: a Gilead Company. Our community of supply chain experts are looking forward to connecting with you in the digital world, including: Christopher Baldwin , Supply Chain Director, Cell & Gene Therapy¸ GSK.

Packaging 52

Packaging Labelling 52

GMPSOP

OCTOBER 28, 2023

The analyst should ensure that the supervisor is notified as soon as an OOS event occurs, the sample is retained, and a documented investigation is commenced. Dealing with out-of-specification results Laboratory result out-of-specification events are a common occurrence in the quality control process.

Documentation 52

Documentation Method Validation Packaging Data Entry 52

GMPSOP

JUNE 28, 2024

Deviations are unusual or unexplained events that can potentially impact product quality, system integrity, or personal safety. Packaging/labeling/Misbranding: 41 warnings vi. Similarly, the packaging, labeling, and misbranding-related warning letters were the top reasons in 2019. What is deviation?

Documentation 59

Documentation Packaging Labelling Pharmaceutical Manufacturing 59

GMPSOP

MARCH 8, 2024

Out of trend results What is the origin of out of specification events? The court ruled that any individual OOS event should be investigated, and if a laboratory error cannot be identified, the batch will fail the test. Each tablet has the label claim of 100mg (w/w). Access to exclusive content for an affordable fee.

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Documentation Dosage Pharmaceutical Manufacturing Packaging 52

GMPSOP

AUGUST 23, 2022

The tool can also be used for any other quality and compliance issues where a risk event is repetitive and a quality decision is urgent. Is this system used in the creation or verification of product labelling (inserts, outserts, cartons or packaging)?

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Documentation Communication Pharmaceutical Manufacturing Labelling 52

Quality Matters

APRIL 26, 2023

FDA are co-hosting the APEC Medical Product Supply Chain Dialogue as a signature event of the U.S. While much has happened since USP’s CoE designation – including the COVID-19 pandemic, advances in technology, and geopolitical realignment in the region – science-based regulatory cooperation remains a key focus for APEC stakeholders.

Prescription Filling 52

Prescription Filling Generic Medicine Packaging Labelling 52

European Pharmaceutical Review

FEBRUARY 22, 2023

The payload is packaged inside a dissolvable needle, loaded within a microsyringe that is attached to a folded, self-inflating balloon. Results from the first open-label, single-centre study of RT-101,6 which was conducted in Australia, were reported at the start of 2020. No serious adverse events were reported.

Biosimilars 105

Biosimilars Diabetes Immunity Immunization 105

Birth Control Pharmacist

SEPTEMBER 20, 2021

While not stated in the current package insert, data are emerging that support fewer breast tissue effects and breakthrough bleeding than older oral contraceptives. Nextstellis (Drospirenone and Estetrol) [package insert]. Available at: www.accessdata.fda.gov/drugsatfda_docs/label/2021/214154s000lbl.pdf. Accessed June 25, 2021.

Adverse Reactions 52

Adverse Reactions Packaging Labelling Diabetes 52

GMPSOP

MARCH 17, 2023

In a packaging line, a printer was used to imprint manufacturing and expiry dates on a batch of empty cartons which will be used to fill tablet strips. Further to corrective action, the defective packaging (carton) lot was destroyed which was initially quarantined. A fresh lot of unprinted cartons was issued for printing.

Documentation 52

Documentation Packaging Process Improvement Pharmaceutical Manufacturing 52

PharmaShots

APRIL 5, 2023

Udenyca is also indicated to increase survival in patients acutely exposed to myelosuppressive doses of radiation The approval was based on the comprehensive analytical data package, along with a PK, PD, and immunogenicity study. The results showed that 1171 out of 1605 patients were originator-naïve, retention rates @1yr.

Biosimilars 49

Biosimilars Packaging Labelling Hospitals 49

PharmaShots

MARCH 1, 2023

osteoporosis in postmenopausal women and men with high fractures risk, treatment-induced bone loss The submission was based on the comprehensive analytical and clinical data package, incl. It will be available as a 300mg concentrate for solution for infusion’ Related Post: Insights+ Key Biosimilars Events of January 2023

Biosimilars 40

Biosimilars Packaging Labelling 40

GMPSOP

MARCH 4, 2023

Quality risk management involves the art and science of identifying, analyzing, assessing, and managing uncertain events. Events that can impact product quality or compliance with registered dossier throughout a product’s life. In most cases, these questions need to be asked before a risk event would potentially occur.

Documentation 52

Documentation Communication Method Validation Packaging 52

GMPSOP

JULY 31, 2023

– High-Speed Tablet/Capsule Counting Machines (Critical for accurate counting and packaging of tablets and capsules). Alarm and safety test: Acceptance Criteria: The autoclave’s alarms should activate and safety interlocks should function correctly when triggered by predefined events or conditions.

Documentation 52

Documentation Dosage Labelling Data Entry 52

The Thyroid Pharmacist

JULY 29, 2022

But massive wildfire events like the ones in Colorado are both a cause and symptom of climate change. 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 52

Health and Personal Care Stores Compounding Immunity Immunization 52

pharmaphorum

JANUARY 30, 2023

More specifically on the current situation, they added, “Recently, shortages have been exacerbated by geopolitical events or trends, such as the war in Ukraine, the energy crisis, high inflation rates, as well as the recent surge of COVID-19 cases in China.” Indeed, China plays a crucial role in the supply of antibiotics.

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Generic Medicine Packaging Labelling 99

RX Note

FEBRUARY 23, 2023

G6PD Deficiency - Explaining G6PD Deficiency Ramadan - Medications during Ramadan fasting Adverse Drug Reactions Adverse Drug Reactions - All adverse reactions are adverse drug event Pharmacovigilance - To detect unreported ADRs Drug Allergy - Management vary based on the signs and symptoms Medicine-induced Discolouration - Red?

HIV Treatment and Prevention Agents 75

HIV Treatment and Prevention Agents Community Pharmacies Labelling Chemotherapy 75

The Thyroid Pharmacist

OCTOBER 27, 2023

Follow package instructions. Follow package directions for each supplement. This can be used in the event of food poisoning, accidental ingestion of a food you’re sensitive to, or for binding mycotoxins and other pathogenic gut infections. Precautions Do not take more than the recommended dose on the label.

Health and Personal Care Stores 96

Health and Personal Care Stores Immunity Immunization Compounding 96

pharmaphorum

MAY 26, 2022

Factors such as ethnicity, gender, sexual orientation and age can contribute to interindividual differences in treatment responses and risks of adverse events. As a Non-Clinical Assessor at MHRA he assessed non-clinical data packages for new and generic medicines. About the authors.

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Packaging Vaccines Generic Medicine Compounding 141

Pharmaceutical Technology

MARCH 21, 2023

Based on the individual contract, these CMOs manufacture small molecules or biological active pharmaceutical ingredients (APIs), as well as packaging material, and are charged with other related functions. Sharp Packaging Services is producing the solid dose of the drug and packaging it.

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Packaging Vaccines Labelling Communication 59

Pharmaceutical Technology

JANUARY 15, 2023

Using the manufacturing contract-related data collated from PharmSource reports, and news from the GlobalData Pharma Intelligence Center, Pharmaceutical Technology has collated some of the key regulatory events from late November to late December that will likely impact manufacturing volumes, and stakeholders that will likely be affected.

Labelling 52

Labelling Packaging Communication Diabetes 52

Pharmaceutical Technology

FEBRUARY 27, 2023

Contract manufacturing organizations (CMOs) not only produce the active pharmaceutical ingredient (API) at the heart of a therapy, but are also responsible for the sterile manufacturing and packaging of liquid and inhalational drug constituents and packaging, depending on the needs of the particular therapy.

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Packaging Chemotherapy Labelling Communication 52