European Pharmaceutical Review

AUGUST 10, 2023

Amidst numerous warning letters distributed by the US Food and Drug Administration (FDA) to pharmaceutical manufacturers in recent months, in July this year, the US regulatory body published its analysis on drug product quality in 2022. Eight FDA warning letters were handed to European companies in 2018.

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Pharmaceutical Commerce

FEBRUARY 13, 2024

Various considerations can help pharmaceutical manufacturers and suppliers provide a robust serialization solution based on the FDA's Drug Supply Chain Security Act.

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Pharmaceutical manufacturing Manufacturing FDA Pharmaceutical 52

Pharma Leaders

MAY 19, 2023

The FDA has released 25 new product specific guidances (PSG) and 21 newly-revised PSGs that the agency provides to assist generic pharmaceutical manufacturers to develop drugs and generate the evidence needed to support ANDA approvals.

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Pharma Leaders

MAY 8, 2023

The Food and Drug Administration (FDA) has successfully inspected Nexus Pharmaceuticals’ pharmaceutical manufacturing facility located in Pleasant Prairie, Wisconsin, US. The inspection will allow the company to commence commercial operations at the three-storey, 84,000ft² manufacturing facility.

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Manufacturing Food and Drug Administration FDA Pharmaceutical manufacturing 52

European Pharmaceutical Review

JANUARY 16, 2023

Under the agreement with the Swiss Confederation (Switzerland), the Swiss Agency for Therapeutic Products (Swissmedic) and the US Food and Drug Administration (FDA) will be able to utilise each other’s GMP inspections of pharmaceutical manufacturing facilities, avoiding the need for duplicate inspections.

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Food and Drug Administration FDA Manufacturing Food 106

World of DTC Marketing

APRIL 12, 2021

The US Food and Drug Administration (FDA) believes the adulteration of heparin was an economically motivated act—a clear breach of the US pharmaceutical supply chain. The second option is to do more random testing of prescription drugs already on the market to ensure they meet FDA guidelines. In other words, money over safety.

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Food and Drug Administration Prescription Pharma Manufacturing 187

eMediWrite

JULY 13, 2023

The CDSCO headquarters conduct regulatory supervision over drug importation, approval of new pharmaceuticals and clinical trials, meetings of the Drugs Consultative Committee (DCC) and Drugs Technical Advisory Board (DTAB), and approval of some licences as the Central Licence Approving Authority.

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Pharma Pathway

OCTOBER 6, 2022

Steril-Gene Life Sciences, Pondicherry (A Group Unit of the Madras Pharmaceuticals) one of the most reputed FDA approved Pharmaceutical manufacturing Company looking suitable Candidates for the below positions. Job Description.

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European Pharmaceutical Review

SEPTEMBER 29, 2022

The US Food and Drug Administration (FDA)’s Center for Drug Evaluation and Research (CDER) through the Office of Pharmaceutical Quality in 2021 embarked on an initiative to develop a framework for establishing a pharmaceutical manufacturing site quality rating system, the Quality management maturity (QMM) programme.

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Management Food and Drug Administration Manufacturing Pharmaceutical manufacturing 74

European Pharmaceutical Review

NOVEMBER 8, 2022

The new law will also require drug manufacturers to pay rebates to Medicare if they increase drug prices faster than consumer inflation. 3) policing anticompetitive settlements between competing drug manufacturers. Citizen Petitions before the FDA. 5) monitoring access to biosimilars. Senate Bill 562 (S.

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Food and Drug Administration Pharma Prescription Manufacturing 52

pharmaphorum

JULY 28, 2022

The pandemic effectively shut down supply chain paths overnight, and as a result, pharmaceutical manufacturers have faced delays and bottlenecks, which have caused drug shortages in healthcare systems. Until the company is found to be in compliance, there will not be a normal distribution of drug products. About the Author.

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Pharma Consulting FDA Manufacturing 98

pharmaphorum

DECEMBER 28, 2022

These teams will include experts in regulatory, GMP compliance and quality systems, often including ex-FDA and MHRA inspectors and industry experts. Due diligence teams will focus on two key areas: the standard of the facilities and the pharmaceutical quality system.

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PM360

MAY 25, 2023

The pandemic had a huge impact on the way population health decision-makers (PHDMs) navigate our industry, and now that it’s clear many of these shifts are here to stay, pharmaceutical manufacturers need to adjust accordingly. PHDMs know contracting alone won’t be enough to solve these challenges. References: 1.

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Pharmaceutical Technology

JUNE 23, 2022

National Resilience (San Diego, California) announced on 6 June that it had raised $625m in series D financing, which will be spent in part on continuous manufacturing for biologics. The US House of Representatives separately passed a bill on continuous manufacturing on 19 October last year.

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Clarify Health

OCTOBER 26, 2021

Food and Drug Administration (FDA) released guidance entitled, Enhancing the Diversity of Clinical Trial Populations — Eligibility Criteria, Enrollment Practices, and Trial Designs Guidance for Industry. To advance equity in clinical research, the U.S. In fact, 73% were White, 14% were Asian, 6% were Hispanic, and 5% were African American.

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Food and Drug Administration Recruitment Pharmaceutical manufacturing Medical 52

PM360

OCTOBER 25, 2023

Combination Therapy in Oncology Combination therapies comprising two or more therapeutic agents have become a cornerstone of oncology management and are increasingly a development focus for the pharmaceutical industry. Food and Drug Administration (FDA) oncology approvals were for drugs used in combination. Certain markets (e.g.,

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Food and Drug Administration Manufacturing Marketing Pharmaceutical manufacturing 105

European Pharmaceutical Review

JULY 21, 2023

Manufacturing delays and capacity issues that continue to impact the pharmaceutical supply chain have led to medicine shortages around the globe; an issue that has been exacerbated further by geopolitical events, the energy crisis and rising inflation.

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European Pharmaceutical Review

OCTOBER 20, 2022

An essential part of the manufacturing of drug products is the use of water of different degrees of purity. Compliance with Annex 1 and FDA requirements imposes high standards for accuracy and precision of the analytical instruments used to assess the quality of water samples. References. US Food and Drug Administration.

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Food and Drug Administration Pharma Manufacturing Food 86

European Pharmaceutical Review

JULY 3, 2023

The Office of Pharmaceutical Quality (OPQ) in the US Food and Drug Administration (FDA)’s Center Pharmaceutical Quality for Drug Evaluation and Research (CDER) has released its 2022 annual report analysing drug manufacturers and their products. FDA’s sampling and testing programme found 892 of 1,552 product samples (57.5

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pharmaphorum

NOVEMBER 25, 2022

The Parma site, as yet only nine months into construction, is due to become operational from 2024, with FDA, IFA, and EMA approvals due to be sought for 2025. In brief, the European plan for Chiesi is in-house drug development of biologicals and rare disease targeting.

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Pharmaceutical Manufacturing Medicine Competition 96

PM360

DECEMBER 20, 2023

Pharmaceutical companies can sell drugs with free pricing in the GBA and Hainan Boao after obtaining foreign approval (e.g., FDA or EMA) and if the “Lecheng Medical Products Administration Bureau” recognizes the status of “clinical urgency.” In these pilot zones, foreign innovative products can be sold without NMPA regulatory approval.

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PM360

AUGUST 9, 2022

The FDA 510(k) submission is expected to take place in Quarter 3 2023. Launched in July 2021, Prescryptive Health provides next-generation, mobile market access and medication adherence solutions for pharmaceutical manufacturers. Orbita Outreach. Patty Riskind. hello@orbita.ai.

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pharmaphorum

OCTOBER 26, 2022

The status isn’t awarded lightly and Chiesi is the largest pharmaceutical manufacturer to be named a B Corp. “We We promptly discussed this need with the FDA and the agency agreed to a proposed amendment of the protocol to accommodate, in a safe manner, the patient access to the EAP.”.

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European Pharmaceutical Review

DECEMBER 18, 2023

Pharmaceutical manufacturing Oligonucleotides Last month, the Centre for Process Innovation (CPI) announced a new Scotland-based manufacturing facility focusing on oligonucleotide therapeutics. ZUMA-7 is the first and largest Phase III study of any CAR T-cell therapy, with the longest follow-up.

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World of DTC Marketing

DECEMBER 10, 2020

Among the 25 worldwide companies that spend the most on research and development—all more than $5 billion a year—seven are pharmaceutical manufacturers, but eight are automobile or automobile-parts companies with profit margins under 10 percent. years to win FDA approval, at a median cost of $648 million.

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Pharmaceutical Technology

AUGUST 30, 2022

International companies investing in the emerging market of Brazilian pharmaceutical manufacturing will see a higher return on investment than from developed market equivalents, if they choose to compete with local manufacturers to supply Brazil’s growing market and the greater South American region.

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Manufacturing Marketing Pharma Distribution 78

PM360

APRIL 25, 2023

biosimilars market to date, the first of eight FDA-approved Humira (adalimumab) biosimilars launched in the United States in January after years of regulatory delays. In perhaps the most significant moment for the U.S. Switching patients from brand to biosimilar, as well as between biosimilars, was also highlighted in the survey.

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Marketing Competition Government Manufacturing 97

European Pharmaceutical Review

AUGUST 9, 2022

Burkholderia species are one of the primary causes of non-sterile pharmaceutical product recalls and accounted for 45.3 percent of recalls recorded by the US Food and Drug Administration (FDA) between 2012 and 2019. Daddy Gaoh et al.

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Pharma Marketing Network

JUNE 11, 2020

I mean, every aspect of the industry from FDA approvals and regulations to the actual nuts and bolts of marketing and what works and what doesn’t work. If you’re a pharmaceutical company or if you’re an agency or even a consultant.

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Pharmaceutical Technology

MAY 11, 2008

” LEVEL TRACKING Pharmaceutical manufacturing company Seidenader Vision has also developed a system – the SATrack and Trace. ” THE DOMINO EFFECT There are many examples of how these technologies have helped make pharmaceutical manufacturing safer for the consumer.

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Pharmaceutical Technology

MARCH 22, 2023

In December 2022, the US passed its ‘ominous spending bill’ directing the US Food and Drug Administration (US FDA) to establish an advanced manufacturing Centre for excellence and an advanced manufacturing technologies designation programme.

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