European Pharmaceutical Review

JANUARY 2, 2024

Over the past several years, the pharmaceutical industry has faced challenges regarding quality assurance in drug development, the author asserted. highlighted that “in the EU market, a relatively low number of approved pharmaceutical products adopted the QbD methodology or describe QbD elements in their regulatory submissions.”

Documentation 101

Documentation 101

The FDA Law Blog

SEPTEMBER 14, 2022

Mullen — As promised in our posts from earlier this summer ( here and here ), we are back to report on our assessment of CDRH’s electronic submission process through its Customer Collaboration Portal (CCP). Say goodbye to your thumb drives and CDs – the CCP electronic submission process couldn’t be easier. It has been seamless.

Documentation 59

Documentation 59

The FDA Law Blog

JUNE 20, 2023

Mullen — On June 2, 2023, FDA issued the latest version of its guidance on Requests for Feedback and Meetings for Medical Device Submissions: The Q-Submission Program. For example, FDA expressly notes that feedback on EUAs is outside the pre-submission process, and pre-submission meetings include videoconferences.

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FDA Documentation Communication 45

STAT

JUNE 16, 2023

’s National Health Service, according to the Prescription Medicines Code of Practice Authority. The Leo manager wanted the pricing information in order to bolster its submission to the U.K.’s This is a self-regulatory body overseen by the Association of the British Pharmaceutical Industry, the trade group.

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Pharmafile

MARCH 31, 2023

Published date: 31/03/2023 Summary: — NDA supported by data from global Phase III FRESCO-2 study in the U.S., Europe, Japan and Australia along with data from Phase III FRESCO study conducted in China — — FRESCO-2 showed fruquintinib treatment reduced the risk of death by 34% in refractory metastatic colorectal cancer (0.66

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FDA 52

Impact Pharmaceutical Services

AUGUST 9, 2022

As a result of repeat business, IMPACT (now part of Syner-G BioPharma Group) was contracted by a large, global pharmaceutical company to author the CSRs and accompanying submission documents to support a simultaneous US and EU submission for a combination respiratory product. and 2.7.2), and the Clinical Overview (Module 2.5).

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Documentation Pharmaceutical Companies Pharmaceutical Companies 40

The FDA Law Blog

APRIL 2, 2024

Finally, FDA asks Congress to amend to FDCA § 505(j) to address the submission and review of drug-device combination product ANDAs, as well as drug products submitted in an ANDA that are used with devices. FDA also asks for recall authority over drugs—both human and animal—to remove violative drug products from market “more quickly”.

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The FDA Law Blog

JUNE 28, 2023

Baumhardt, Senior Medical Device Regulation Expert & Philip Won — The Center for Devices and Radiological Health’s (CDRH) Standards and Conformity Assessment Program (S-CAP) encourages medical device sponsors to use FDA-recognized voluntary consensus standards in their product submissions.

Documentation 52

Documentation FDA 52

pharmaphorum

MARCH 2, 2021

For example protocol management, CRF design , metadata management, and the collection, analysis, and submission of compliant clinical study data to regulatory authorities. Our automated processes are streamlined for CRF design, data collection, tabulation, analysis, and submission. Automated processes and clinical MDRs.

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Patient Care FDA 115

European Pharmaceutical Review

MARCH 25, 2024

The Committee for Medicinal Products for Human Use (CHMP) has recommended granting of a marketing authorization for antibiotic combination Emblaveo® (aztreonam-avibactam) for treatment of complicated intra-abdominal and urinary tract infections, hospital-acquired pneumonia and infections caused by certain types of aerobic Gram-negative bacteria.

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Hospitals 96

European Pharmaceutical Review

APRIL 17, 2024

Roche multiple sclerosis subcutaneous injection: late-breaking data “Updated results from OCARINA II further underline the potential benefits of subcutaneous OCREVUS for patients with both relapsing and progressive forms of MS,” shared Scott Newsome , DO, lead author, Johns Hopkins University School of Medicine.

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FDA 73

The Guardian - Pharmaceutical Industry

MARCH 23, 2023

On Thursday afternoon the Therapeutic Goods Administration (TGA) published the almost 4,000 public submissions made in response to the government’s proposed vaping reforms, aimed at tackling rising youth vaping rates and a burgeoning black market.

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Pharmaceutical Technology

DECEMBER 18, 2022

The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended granting variation to the marketing authorization (MA) for Moderna ’s Spikevax bivalent Original/Omicron BA.1 1 (mRNA-1273.214) booster for usage in children aged six to 11 years.

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Vaccines Communication 121

The FDA Law Blog

FEBRUARY 7, 2023

Pre-market requirements include those for obtaining marketing authorization, including 510(k) clearance (21 C.F.R. Part 807, Subpart E), De Novo authorization (21 C.F.R. Part 860 Subpart D), or PMA approval (21 C.F.R. Part 814), and for conducting clinical trials (21 C.F.R. Part 803), and reporting corrections and removals (21 C.F.R.

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Documentation FDA Labelling 98

PharmaShots

JANUARY 23, 2023

In collaboration with Eli Lilly, HUTCHMED focuses on late-stage clinical trials & commercialization of fruquintinib in mainland China, approved under the brand name Elunate The marketing authorization submissions in the US, EU & Japan are planned to complete in 2023 with rolling submission to the US FDA in H1’23.

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FDA 40

Pharmaceutical Technology

SEPTEMBER 29, 2022

The European Medicines Agency (EMA) has accepted Moderna ’s submission seeking a variation to the Conditional Marketing Authorization (CMA) for assessing a 50µg dose of the Omicron-based bivalent Covid-19 booster candidate, mRNA-1273.222, for adults aged 12 years and above. 5 subvariants of Omicron. 1 subvariant, mRNA-1273.214.

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Vaccines 59

PharmaShots

JUNE 26, 2023

Shots: The EMA’s CHMP has recommended Soliris for marketing authorization in the EU to treat refractory gMG in children & adolescents aged 6-17yrs. who are AChR Ab+. The efficacy & safety were consistent with the established profile of Soliris incl.

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ISPE

SEPTEMBER 15, 2023

From advanced therapies within combination products to the evolving concept of Quality Management Maturity (QMM), and global harmonization approaches such as global structured submissions, ICH Q12, Q14, and M4Q. Advanced therapies within combination products represent a frontier where pharmaceutical innovation meets medical technology.

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FDA Pharmaceutical Companies Pharmaceutical Companies Patient Care 98

PharmaShots

APRIL 3, 2023

Shots: The EMA’s CHMP has recommended Ultomiris for marketing authorization in the EU for adult patients with NMOSD who are anti-aquaporin-4 Ab+ The opinion was based on the P-III trial (CHAMPION-NMOSD) evaluating Ultomiris in 58 patients across North America, the EU, Asia-Pacific & Japan.

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pharmaphorum

DECEMBER 23, 2022

And technology like digital asset management (DAM), medical, legal, and regulatory review (MLR), and content authoring tools will help drive further acceleration.”. “As Dynamic digital content will drive MLR, health authority collaboration. For example, allowing one submission for 20 versions of an email to support personalisation.

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Patient Care 105

PharmaShots

MAY 11, 2023

The regulatory submissions are under review with multiple health authorities, incl. in the US & Japan Ref: AstraZeneca | Image: AstraZeneca Related News:- AstraZeneca Receives EMA’s CHMP Positive Opinion Recommending Marketing Authorization of Ultomiris (ravulizumab) for Neuromyelitis Optica Spectrum Disorder PharmaShots!

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PharmaShots

APRIL 27, 2023

Shots: The US FDA has granted Breakthrough Device Designation for Ultromics’ EchoGo Amyloidosis, an AI-enhanced platform that detects cardiac amyloidosis by using AI to analyze echocardiograms EchoGo Amyloidosis platform is intended to be included within the company’s EchoGo Platform (developed in conjunction with various clinical collaborators (..)

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FDA 40

European Pharmaceutical Review

MAY 18, 2023

There is a need to optimise the notifications of potential and actual shortages, including earlier submission of notifications in advance of potential shortages and improving the accuracy of the detail provided to maximise the opportunities to prevent potential shortages from being realised or limiting their impact,” the document concludes.

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Documentation Communication 95

Pharmaceutical Technology

AUGUST 9, 2022

Health Canada has accepted the New Drug Submission (NDS) of Endo International subsidiary Paladin Labs for cenobamate tablets as an adjunctive treatment to manage partial-onset seizures in adult epilepsy patients. The treatment is intended for such patients who are not well-controlled with standard therapy.

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Labelling 98

Impact Pharmaceutical Services

AUGUST 9, 2022

Hosted software to publish regulatory submissions in the electronic common technical document (eCTD) format was deployed. The group successfully submitted a “pilot” eCTD submission to the Food and Drug Administration (FDA) and gained FDA approval to transmit submissions through the Electronic Submissions Gateway (ESG).

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FDA Packaging Documentation 40

Pharmaceutical Technology

AUGUST 23, 2022

Pfizer and BioNTech have filed an application seeking Emergency Use Authorization (EUA) from the US Food and Drug Administration (FDA) for a booster dosage of an Omicron BA.4/BA.5-adapted The submission comes after the regulatory agency provided guidance to incorporate clinical findings of the bivalent Omicron BA.1-adapted

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Vaccines FDA Dosage 52

The FDA Law Blog

SEPTEMBER 21, 2022

For COVID-19, an experienced developer is one who has only “interacted with FDA through an EUA request or pre-EUA submission,” regardless of success. However, it was not always clear to developers, prior to submission of an EUA request, whether their test would satisfy the priority criteria.

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FDA Immunization 52

The FDA Law Blog

NOVEMBER 5, 2023

During this time, he deftly led multi-disciplinary teams, comprised of engineers, scientists, and clinicians, in the review of intricate submissions that left an indelible mark on the industry.

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FDA 52

The FDA Law Blog

JULY 10, 2023

Lenz, Principal Medical Device Regulation Expert — It takes a significant amount of time, cost, and effort to prepare a premarket notification 510(k) submission. Table 1 below shows the 510(k) submission process based on the MDUFA III Performance Goals. FDA Day (in calendar days) FDA Actions Day 1 FDA receives 510(k) submission.

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FDA Documentation Packaging Communication 75

Impact Pharmaceutical Services

AUGUST 9, 2022

Over the next year, IMPACT authored the following documents for the client: Pre-NDA meeting package. Working with the company’s electronic publishing vendor to ensure that fully-compiled, submission-ready documents were produced. 5 clinical study reports. and 2.7.4), and the Clinical Overview (Module 2.5).

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Documentation FDA Packaging Labelling 40

Impact Pharmaceutical Services

AUGUST 9, 2022

Over the next year, IMPACT authored the following documents for the client: Pre-NDA meeting package. Working with the company’s electronic publishing vendor to ensure that fully-compiled, submission-ready documents were produced. 5 clinical study reports. and 2.7.4), and the Clinical Overview (Module 2.5).

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Documentation FDA Packaging Labelling 40

PharmaShots

APRIL 6, 2023

Shots: The company has submitted the variation application to the EMA for marketing authorization of Livmarli to extend the label in patients aged ≥2mos.

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Labelling FDA 40

ISPE

OCTOBER 28, 2022

Health Sciences Authority of Singapore. Paul indicated that not all PIC/S member authorities directly adopt PIC/S Guides. She said that the learnings from the pilot program could result in the scope of collaborative hybrid inspections being increased and other regulatory authorities invited to participate in an expanded program.

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FDA Vaccines Dosage Documentation 97

pharmaphorum

APRIL 22, 2022

In March 2022 , Leela Barham argued that, in light of new highs in the number of non-submissions to UK’s HTA agency, NICE, it was time to ask companies why they choose not to submit. The ABPI surveyed their members in March 2021, including questions relating to terminated appraisals for non-submissions to NICE between 2016 and 2021.

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The FDA Law Blog

NOVEMBER 15, 2022

First application submission fee waiver. One-time first submission fee waiver for a small business with gross receipts of sales $30 million or less. Note: changing the intended use from pediatric to adult requires the submission of a new 510(k) and is subject to user fees. National Taxing Authority Certification).

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FDA Documentation Communication 59

European Pharmaceutical Review

JANUARY 24, 2023

Marketing authorisation submissions for fruquintinib are planned in the US, Europe and Japan in 2023. In December 2022, HUTCHMED initiated a rolling submission of a New Drug Application (NDA) for fruquintinib with the US Food and Drug Administration (FDA). This is planned to be completed in the first half of 2023.

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FDA 52

Pharmaceutical Technology

SEPTEMBER 15, 2022

Veru intends to file an application through the ‘NDS CV’ submission type with Health Canada for the therapy. In June, Veru sought emergency use authorization (EUA) from the US Food and Drug Administration (FDA) for the therapy. . in morality versus placebo. . reduction in deaths compared to placebo. “It

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Hospitals FDA 52