FDA Law Blog: Biosimilars

JUNE 28, 2023

As part of that effort, Accreditation Scheme for Conformity Assessment (ASCA) is designed to reduce FDA review time, reduce and/or remove Sponsor guesswork on documentation to provide in a premarket submission, and improve the quality of testing conducted. The MDUFA V reauthorization converts the ASCA Pilot to a permanent program.

Documentation 52

Documentation 52

pharmaphorum

SEPTEMBER 28, 2022

The nine-company pilot launched in 2017 and is designed to explore a new approach to regulating digital health, based on certifying companies and their internal processes rather than individual devices and apps. The Pre-Cert pilot report. O’Leary said.

Documentation 135

Documentation 135

Eye on FDA

AUGUST 10, 2023

The number of press releases issued by FDA during the first six months of the year declined to 101 from the 125 issued by June 30 of last year, the lowest number at mid-year since 2017. In 2018, FDA issued a much larger number of releases – trend that continued through 2022, all years with much larger numbers than were seen in 2017.

Communication 80

Communication Documentation 80

RX Note

NOVEMBER 19, 2023

On the other hand, Medical Nutrition Therapy Guidelines for Critically Ill Adults is published by Malaysian Dietitians Association in 2017. This handbook complements the limited info available in Paediatric Protocols for Malaysian Hospitals. There is also a chapter of nutritional support in Critical Care Pharmacy Handbook, 2020.

Hospitals 52

Hospitals Documentation Compounding 52

Pharma in Brief

DECEMBER 3, 2023

Full actions (2017–present). The most significant amendments came into force in September 2017, when the Regulations were completely overhauled (discussed here ). The first section 6 actions under the amended Regulations were started in December 2017 (discussed here ). Where we are now Staying power. Fast-paced.

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Biosimilars Dosage Documentation 52

Pharma in Brief

JANUARY 20, 2021

Also on January 18, 2021, the FC issued a new Practice Direction outlining its Document Retention Schedule, including new plans for the destruction of certain archived documents. Gowning for in-person hearings remain subject to the Notice of February 6, 2017. Service of Documents. Document Retention Schedule.

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Documentation 52

Pharma in Brief

MAY 29, 2023

On May 12, 2023, Health Canada announced the release of an updated version of the Guidance Document: Certificates of Supplementary Protection ( CSP Guidance ). Links: Notice: Publication of the Guidance Document: Certificates of Supplementary Protection – Canada.ca Certificate of Supplementary Protection Regulations , SOR/2017-165

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Documentation 59

Pharma in Brief

OCTOBER 29, 2020

These new consolidated FC Guidelines address many of the topics raised in the following earlier FC Notices to the Profession: Case management: Increased Proportionality in Complex Litigation before the Federal Court (June 24, 2015) ; Trial Management Guidelines (April 2017) ; Intellectual Property (experimental testing) (May 12, 2016) ; and.

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Documentation 52

European Pharmaceutical Review

DECEMBER 9, 2022

The Global Antimicrobial Resistance and Use Surveillance System (GLASS) report 2022 by the World Health Organization (WHO), which contains AMR trends for the first time since 2017, showed that common bacterial infections are becoming increasingly resistant to treatments. Data from the 2022 GLASS report.

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Hospitals Documentation 82

Pharmacy Joe

NOVEMBER 22, 2023

This is not the first time the US has dealt with a shortage of this product as back in 2017 there was a nationwide shortage due to manufacturing delays. The current guidance in the Pfizer document states: Limited inventory released direct and to wholesalers/distributors in part or full when available.

Hospitals 52

Hospitals Inpatient Documentation 52

Pharmacy Joe

NOVEMBER 22, 2023

This is not the first time the US has dealt with a shortage of this product as back in 2017 there was a nationwide shortage due to manufacturing delays. The current guidance in the Pfizer document states: Limited inventory released direct and to wholesalers/distributors in part or full when available.

Hospitals 52

Hospitals Inpatient Documentation 52

Express Pharma

AUGUST 2, 2023

The Government has already made its intent clear in the National Health Policy 2017 about creating the Digital Health Ecosystem and has moved to institutionalising technology adoption in healthcare through ABDM. What are the policy initiatives we need for India to reap the insights of digital health solutions available today?

Hospitals 98

Hospitals Nursing Homes Documentation 98

RX Note

NOVEMBER 13, 2023

Registered companies Governed under Companies Act 1965 (companies registered before 2017) or Companies Act 2016 (companies registered since 1 January 2017). Records and documentations should be kept and updated systematically as stipulated by the law. Make your application through MyPharma-C website.

Community Pharmacies 52

Community Pharmacies Health and Personal Care Stores Documentation Independent Pharmacies 52

pharmaphorum

APRIL 27, 2021

Briefing documents published by the FDA ahead of the meeting suggest that discussion will focus on ongoing trials that may serve as alternative confirmatory studies. A similar trial called Impassion131 of Tecentriq with regular paclitaxel flopped, and even suggested patients treated with paclitaxel alone may have fared better.

Chemotherapy 87

Chemotherapy Documentation Drug Development 87

FADIC

OCTOBER 20, 2023

■ All follow-up evaluations and interactions with the patient and his or her other healthcare professional should be included in MTM documentation. This increases direct patient care practice abilities, creates awareness among intensive care team, and prevents medication errors. ■ Frequency of dose and administration time.

Health and Personal Care Stores 52

Health and Personal Care Stores Documentation Medication Therapy Management (MTM) Medical Records 52

Pharmaceutical Technology

NOVEMBER 4, 2022

The letter reported that the UK fell from fifth place in 2017 to seventh in 2020 for the number of Phase III clinical trials initiated across the world. Furthermore, reportedly, only 68% of medicines approved by the EMA were made available in England between 2017 and 2020.

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Documentation Pharmaceutical Companies Pharmaceutical Companies 93

Safe Biologics

FEBRUARY 1, 2024

Over the years, the WHO has attempted to evaluate the BQ: a provisional implementation of the programme was suggested in 2016, and in 2017 a pilot BQ project was discussed. Other supporting agencies await the WHO implementing a global system. In 2018, the project was put on hold for data gathering.

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Biosimilars Documentation Drug Pricing 130

pharmaphorum

OCTOBER 11, 2022

It is subject to a two-year clinical stopping rule, as for now it remains uncertain the benefits of the regimen extend beyond that timepoint and whether continuing to give it will remain cost-effective, according to the SMC’s assessment document.

Chemotherapy 52

Chemotherapy Documentation 52

Syner-G

APRIL 27, 2023

In addition, the OPEN Act, introduced in 2017, can extend the exclusivity period of a previously approved drug by another six months. Each component of the application must be addressed completely and provide detailed information.

Drug Development 52

Drug Development Documentation 52

Pharmaceutical Technology

SEPTEMBER 15, 2022

Bristol Myers Squibb (BMS) documented a 9.1% All top 20 biopharmaceutical companies recorded positive compound annual growth rates (CAGRs) in revenue during 2017–21, with BioNTech (319%) and Moderna (208%) leading thanks to their Covid-19 vaccine franchises.

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Vaccines Drug Pricing Biosimilars Documentation 108

Eye on FDA

JANUARY 9, 2022

As noted in the past, there are two primary means for understanding the agency’s latest thinking with respect to promotional communications from pharmaceutical companies – the content and pattern of enforcement and the issuance of guidance documents to shed light on the parameters that exist.

Communication 64

Communication Documentation Labelling Pharmaceutical Companies 64

pharmaphorum

FEBRUARY 26, 2021

From 2015 to 2017, when the cost of the drug was falling, the three suppliers exchanged information about prices, the volumes they were supplying, and Alissa’s plans to enter the market,” said the CMA.

Documentation 52

Documentation 52

pharmaphorum

DECEMBER 28, 2022

This review will include key documents such as minutes of management review meetings and quality metrics which will enable them to quickly assess the company’s approach to quality and compliance and the current level of control. She joined NSF in 2017.

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Pharmaceutical Manufacturing Documentation Pharmaceutical Companies Pharmaceutical Companies 119

pharmaphorum

APRIL 6, 2021

A Life on Wheels started out as Ross’ hobby back in 2017 and has been growing steadily ever since. It started as a hobby, just a way of documenting my life as a young man with a disability that I could look back on in years to come,” he says. A resonating hobby.

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Documentation 132

FDA Law Blog: Biosimilars

JUNE 19, 2023

And regulating LDTs through guidance documents is vulnerable to legal challenge on procedural grounds. Would there be a new regulatory framework, as is proposed in VALID and outlined in FDA’s 2017 discussion paper (see our prior post here ), or something different? See , e.g. , ACLA White Paper on LDTs here.

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Documentation 56

pharmaphorum

JULY 27, 2022

Of all products approved by the European Medicines Association (EMA) between 2017 and 2020, 68% are currently available in England, a figure that stands at 54% in Scotland. They show that England was sixth and Scotland tenth out of 13 countries when ranked according to the percentage of new medicines made available to patients.

Documentation 98

Documentation 98

pharmaphorum

MARCH 18, 2021

First approved for mantle cell lymphoma (MCL) in 2017, Calquence sales have rocketed since its approval for CLL towards the end of 2019, rising to $522 million in 2020 from $164 million in the prior year. Daiichi Sankyo gets okay for cholesterol drugs.

Hospitals 52

Hospitals Chemotherapy Documentation 52

pharmaphorum

JANUARY 18, 2022

POST CONFERENCE WORKSHOP A: EU MDR 2017/745 Article 117 Requirements. Understand requirements to facilitate the documentation preparation needed to obtain a NB Opinion. BOOK BY 31 st JANUARY AND SAVE $200. BOOK BY 28 TH FEBRUARY AND SAVE $100. Registrations can be made on the event website at: www.pfsamericas.com/. .

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Packaging Documentation Vaccines Drug Development 52

Pharmacy Joe

NOVEMBER 17, 2021

Both the prescriber and pharmacist were required to document the source of the patient’s U-500 insulin dose in the electronic record, as well as which device the patient used to draw their U-500 insulin dose at home (U-100 insulin syringe, TB syringes, etc). In phase two, which began in mid 2017, the following enhancements were made: 1.

Hospitals 40

Hospitals Communication Inpatient Documentation 40

Pharma in Brief

JANUARY 9, 2022

The intent of the draft guidance document is to describe Health Canada’s expectations for manufacturers who distribute prescription drug information through an electronic means, such as a website or mobile app, that is directly linked to a product’s packaging or label. 2021 in the Courts. (a) a) PM(NOC) Regulations decisions.

Documentation 52

Documentation Labelling Vaccines Packaging 52

ID Stewardship

APRIL 13, 2023

09.01.01), which went live in January of 2017. An important accompanying document for Joint Commission standards are Critical Access Hospital Accreditation Survey Activity Guide, for which the January 2023 guide can be found here. ” Given that we cannot be everywhere all the time, how can this be demonstrated?

Hospitals 94

Hospitals Inpatient Documentation Communication 94

European Pharmaceutical Review

JANUARY 25, 2024

These standardised documents provide meticulously curated and scientifically approved information. 2017) “Danmark har flest smartphones i hele verden”, Berlingske, Eurostat (2022) “Medicine Use Statistics” European Commission. Article 63 EMA (29 January 2020).

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Packaging Documentation Communication Pharmaceutical Companies 79

FDA Law Blog: Biosimilars

FEBRUARY 29, 2024

FDA-2017-E-5106 ), and concerns FDA’s October 19, 2016 Accelerated Approval of BLA 761038 for LARTRUVO (olaratumab). According to documents in the PTO’s Patent Center, Lilly has not yet filed a response. 8,128,929 [] for [PTE] request under 35 U.S.C. § The PTE application for U.S. 8,128,929 was submitted on December 8, 2016 (Docket No.

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Documentation 59

Ramblings of a pharmacist

SEPTEMBER 23, 2021

6) Of the 109 prescriptions containing a BP, 40 were uncontrolled at above 130/80 based on the 2017 AHA/ACC guidelines. I also plan to document and transmit a Pharmacist's e-Care plan to CPESN USA when I do follow up (because if it isn't documented it didn't happen!) BP and height/weight for adults are optional fields.

Community Pharmacies 40

Community Pharmacies Documentation Independent Pharmacies Hospitals 40

pharmaphorum

JANUARY 27, 2023

Then, at the end of the study, [making sure] that all of the study documentation, [the] study report, matches up with everything that has happened during the study. It really enables the smooth running of studies.”

Vaccines 111

Vaccines Pharmaceutical Companies Pharmaceutical Companies Documentation 111

FDA Law Blog: Biosimilars

DECEMBER 4, 2023

Prescribing Red Flags The government alleged that from at least 2017 to April 2021 Defendants knowingly filled controlled substance prescriptions “that raised obvious ’red flags’ of potential abuse or diversion.” If the pharmacist can resolve it, they must make a record of the resolution. Complaint ¶ 55.

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Controlled Substances Documentation Dosage Prescription Filling 139

pharmaphorum

APRIL 16, 2021

The longer term impact of 2020 on clinical trial activity, given widely documented pauses on trials, will only be evaluable in coming years. The longer term impact of 2020 on clinical trial activity, given widely documented pauses on trials, will only be evaluable in coming years.”

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Pharmaceutical Companies Pharmaceutical Companies Vaccines Documentation 94