FDA Law Blog: Biosimilars

JULY 10, 2023

Performance Metric FY 2018 FY 2019 FY 2020 FY 2021 FY 2022 Average Number of FDA Days to MDUFA IV Decision 72.62 In this case, the FDA clock start date is determined as the date of receiving the submission by the Document Control Center (DCC). Attachment number) and document name or description as appropriate.

Documentation 75

Documentation Packaging Communication Labelling 75

RX Note

JUNE 5, 2023

The Hidden Truth Studies have shown that the antineoplastic residues can be found be on the external packaging of both oral and IV drugs. Change gloves every 30 minutes during compounding or immediately when damaged or contaminated, unless otherwise recommended by the manufacturer's documentation.

Compounding 52

Compounding Packaging Hospitals Chemotherapy 52

European Pharmaceutical Review

JANUARY 25, 2024

These standardised documents provide meticulously curated and scientifically approved information. Article 63 EMA (29 January 2020). Within the EU, patient information leaflets (PILs) are not merely a regulatory requirement but a cornerstone of patient safety. 11 This requirement directly contradicts what is included in Article 63.

Packaging 98

Packaging Documentation Communication Pharmaceutical Companies 98

Pharmaceutical Technology

APRIL 14, 2023

Although the organisation previously shared a draft version of the report in February, the revised document features new details on the drugs’ potential fair pricing. Obeticholic acid will be in the spotlight when an approval package for its use in NASH will be discussed at a Gastrointestinal Drugs Advisory Committee meeting on May 19.

Packaging 52

Packaging Documentation 52

GMPSOP

JUNE 28, 2024

Additional documents included each month. Packaging/labeling/Misbranding: 41 warnings vi. In 2019 and 2020, warning letters were issued for “Adulterated Food and Supplements” at 36% and 33%, respectively. Similarly, the packaging, labeling, and misbranding-related warning letters were the top reasons in 2019.

Documentation 59

Documentation Packaging Labelling Pharmaceutical Manufacturing 59

Proxsys Rx

APRIL 19, 2024

Two potential 340B developments for 2024 In an article dated January 5, the subscriber-only website 340B Report projected that “In 2024, congressional gridlock and election year dynamics will likely slow momentum on any comprehensive 340B program reform package.”

Specialty Pharmacies 52

Specialty Pharmacies Hospitals Drug Pricing Packaging 52

Proxsys Rx

AUGUST 28, 2024

Ironically, their average gross profit margin in 2020 was over 73%. Customized 340B software should be able to automatically document the journey of every eligible prescription written — from the providers to the retail and specialty contract pharmacies, and from billing to claiming-and-qualifying for 340B reimbursement.

Specialty Pharmacies 52

Specialty Pharmacies Hospitals Communication Packaging 52

European Pharmaceutical Review

NOVEMBER 24, 2022

Indeed, a 2020 operation coordinated by Europol across 27 countries led to the seizure of more than 25 million units of counterfeit anticancer drugs and erectile dysfunction medicines among other fake drugs worth nearly €73 million. One area in which the problem can be tackled effectively is product packaging.

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Packaging Labelling Documentation Dosage 111

GMPSOP

MARCH 3, 2024

Cross contamination is dangerous in pharmaceutical industry as it can severely compromise patient safety if the content is not pure and the product package differs from what is written on the label. – According to WHO report on 20 th April 2020, 1 in 10 people fall ill after eating contaminated food worldwide.

Health and Personal Care Stores 52

Health and Personal Care Stores Labelling Packaging Documentation 52

pharmaphorum

JANUARY 18, 2022

million in 2020 and with the rapid growth of the industry, is expected to grow at a CAGR of 8.95% up to 2027. Primary Packaging material designers. Secondary packagers. Understand requirements to facilitate the documentation preparation needed to obtain a NB Opinion. Who should Attend: Drug-delivery developers.

Packaging 52

Packaging Documentation Drug Development Vaccines 52

PharmaTech

JUNE 23, 2025

It builds on drug calculations topics previously described (1), including guidance documents (2–5). FDA guidance documents illustrate labeling salt drugs and associated active moieties. From the Dilantin package insert: “The free acid form of phenytoin is used in DILANTIN-125 Suspension and DILANTIN Infatabs. Phenytoin Dosage.

Compounding 52

Compounding Dosage Labelling Drug Development 52

Pharma in Brief

JANUARY 9, 2022

In response to the COVID-19 pandemic, in 2020, the Minister of Health signed interim orders designed to streamline the process to authorize the importation or sale of drugs, vaccines, and medical devices used to diagnose, treat, mitigate, or prevent COVID-19. Major Policy Initiatives. (a) a) COVID-19.

Documentation 52

Documentation Labelling Vaccines Packaging 52

The Thyroid Pharmacist

JULY 29, 2022

I was inspired to write this blog after the September 2020 Cameron Peak fires in Colorado. Feel free to use my own health timeline as a guideline to document your health journey. Most filter manufacturers have pictures on their filter packaging that indicate what they will and will not filter, along with the MERV rating.

Health and Personal Care Stores 52

Health and Personal Care Stores Compounding Immunity Immunization 52

pharmaphorum

FEBRUARY 2, 2022

As the COVID-19 pandemic ricocheted around the world at the start of 2020, researchers were faced with a stark choice – go remote or go home. Through a series of workshops and surveys, which collected the views of research professionals, patients and carers, the group has developed a new guidance document. A practical consensus.

Documentation 52

Documentation Packaging Communication 52

RX Note

FEBRUARY 9, 2025

Introduction A unit-dose medication distribution system uses medications packaged in unit-dose or single-unit packages. A single-unit package contains one dosage form of medication (e.g., A unit-dose package contains the dose of a medication ordered for a patient (e.g. one capsule, one 5 ml volume of liquid, etc.).

Packaging 40

Packaging Labelling Dosage Documentation 40

RX Note

FEBRUARY 23, 2023

Figures - Elemental iron and calcium content?

HIV Treatment and Prevention Agents 58

HIV Treatment and Prevention Agents Community Pharmacies Labelling Chemotherapy 58

Ramblings of a pharmacist

OCTOBER 26, 2022

In July 2020, a pharmacy in Brawley, CA was attempting to obtain Biktarvy® for their patients at a price that would sustain the pharmacy practice – i.e. a price that is less than the insurance’s allowed amount. The result of this will absolutely be that counterfeit medications WILL make their way into the drug supply chain.

Documentation 40

Documentation Labelling Independent Pharmacies Community Pharmacies 40