Pharma Mirror

MARCH 10, 2021

The report anticipates breakthroughs in multi-modal disease therapies within five years, mRNA platforms to transform many new non-infectious disease treatment options, and huge growth in contract services due to the recent surge in IND applications – with 75 annual FDA approvals expected by 2025.

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FDA 52

Pharma Mirror

JANUARY 28, 2022

.’s (“Labnovation”) COVID-19 Antigen Rapid (“ART”) Test Kit, which is imported by Clearbridge and registered for use in the Philippines, has been recently approved by the Food and Drug Administration (“FDA”) of the Philippines for self-testing.

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FDA 52

Pharma Mirror

MARCH 22, 2022

The post metaMe Health partners with Indegene to launch Regulora(R), an FDA-cleared Prescription Digital Therapeutic for adults with Irritable Bowel Syndrome appeared first on Pharma Mirror Magazine. According to a survey of nearly 2,000 patients, IBS sufferers.

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FDA 52

Pharma Mirror

JANUARY 5, 2024

Spearheaded by a former US FDA Investigator and seasoned pharmaceutical executive, FD-AID is uniquely positioned to bring a wealth of expertise and insight to India’s rapidly growing pharmaceutical industry.

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FDA 52

Pharma Mirror

OCTOBER 1, 2020

However, this medication had recently raised controversies when the Food and Drug Administration (FDA) announced a product recall of this drug from the market due to the presence of. The post 6 Reasons Why Ranitidine Is Harmful and How It Caused Cancer to Many appeared first on Pharma Mirror Magazine.

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FDA 52

The FDA Law Blog

APRIL 25, 2024

Promotional labeling is generally any labeling other than FDA-required labeling that is devised for the promotion of a product, as well as other functions, and can include printed, audio, or visual matter that describes the product. l)(1) (e.g., l)(1) (e.g.,

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Labelling Communication FDA 59

Pharma Mirror

NOVEMBER 7, 2023

In the United States, for example, the Food and Drug Administration (FDA) plays a central role, while the European Medicines Agency (EMA) oversees regulations in the European Union. Good Manufacturing Practices The post Navigating Regulatory Compliance in the Pharmaceutical Industry appeared first on Pharma Mirror Magazine.

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FDA 52

Pharma Mirror

OCTOBER 16, 2023

The first mRNA drug (BNT162b2 vaccine) was granted emergency use authorization by the FDA in December 2020 and approved for marketing in August 2021. The first mRNA drug (BNT162b2 vaccine) was granted emergency use authorization by the FDA in December 2020 and approved for marketing in August 2021.

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Immunization Vaccines FDA 52

Pharma Mirror

SEPTEMBER 8, 2023

Niclosamide was approved by the US FDA in 1982 but it is not currently available for human The post Repurposing the anthelmintic drug Niclosamide appeared first on Pharma Mirror Magazine. This drug is present in the Model List of Essential Medicines from the World Health Organization, used since the 1960s for tapeworm infection.

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FDA 52

Pharma Mirror

JANUARY 4, 2022

The findings suggest that there will be 30+ FDA new drug approvals in the next year, more than five commercial COVID vaccines – resulting in a production squeeze at CDMOs and consequentially higher margins and profits for supply side companies – with mRNA, advanced therapies.

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Vaccines FDA 52

Pharma Mirror

NOVEMBER 25, 2021

Designed to guarantee the optimal functioning of any freeze dryer, irrespective of the brand, Usifroid platform integrates a global service of improvement technical support to freeze drying processes around the world while ensuring its adaptation to the latest industrial requirements standards and GMP and FDA recommendations in the field of.

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FDA 52

Pharma Mirror

JANUARY 6, 2021

In the United States, the Food and Drug Administration (FDA) set out some very broad guidelines concerning nutrients that should be included in baby formula. The post Choosing a Baby Formula appeared first on Pharma Mirror Magazine.

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FDA 52

Pharma Mirror

OCTOBER 15, 2021

.– Borody’s track record includes effective treatment for Peptic Ulcers & Crohn’s Disease, recolonisation of bowel microbiome, and 3 FDA approved drugs on the market.– The post Topelia Australia launches US$25M Series A call for COVID-19 ATT Ziverdox appeared first on Pharma Mirror Magazine.

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FDA 52

Pharma Mirror

FEBRUARY 18, 2021

Capable of delivering any FDA approved. The post Maculus Therapeutix welcomes Privity FZ LLE and Prepares Capital Raise for Novel Drug Delivery Platform appeared first on Pharma Mirror Magazine. Maculus achieved the breakthrough using a patented novel tunable biodegradable proprietary product, MacuBloc.

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FDA 52

ISPE

FEBRUARY 13, 2023

Vivien Santillan, ISPE Philippines Affiliate Vice President, concurred adding “I have personally witnessed his dedication in his field as he has also assisted the Philippines and unselfishly shared his knowledge and expertise with the industry and the FDA.

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Documentation FDA 98

pharmaphorum

JANUARY 18, 2021

Historical performance data, like that provided in FDA Drug Trials Snapshots, has shown that using traditional recruitment practices by themselves does not enhance the diversity of clinical trial populations. The post A collaborative approach to greater diversity in clinical trials appeared first on.

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FDA 52

Pharma Mirror

OCTOBER 7, 2021

The post Medical Writing — An Outsourcing Competency appeared first on Pharma Mirror Magazine. As a result, well-designed manuscripts can be published faster, and results can reach the public faster and more cost-effectively.

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FDA 52

pharmaphorum

JUNE 4, 2021

This article appears in our free digital magazine Deep Dive: Market Access 2021. The FDA, for example, has gone back and forth on whether to keep a truncated digital health pathway implemented during COVID-19 in place after the pandemic. The post “A long way to go” for digital health reimbursement appeared first on.

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Compounding FDA 45

pharmaphorum

DECEMBER 14, 2020

Medscape’s Adrian Duncan explores findings from an FDA trial looking at the impact of digital medical education on antibiotic prescribing. Emma Sutcliffe explains how to build partnerships that are not defined by the volume of the interactions but instead by the value that each interaction brings to all stakeholders.

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Pharmaceutical Companies Pharmaceutical Companies FDA 76

pharmaphorum

JUNE 2, 2022

While the number of drugs approved by the FDA has increased significantly in the last 5 years , average peak sales have declined since 2010. Download the magazine to: Learn the foundations of omnichannel transformation. Measure your omnichannel maturity with our proprietary tool. Embrace a modular approach to content development.

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Communication FDA 52

pharmaphorum

MARCH 19, 2021

FDA data indicates that while the number of orphan designations has been increasing over the last half-decade, the number of unique indications has been decreasing 3. Read the rest of the article in Delta magazine – rare disease unpacked. The post Making a big impact in small patient populations appeared first on.

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Pharmaceutical Companies Pharmaceutical Companies FDA 52

Pharma Marketing Network

JULY 7, 2021

Pfizer’s partnership with BioNTech is one example of what Forbes’ Magazine dubbed “ The Great Coronavirus Collaboration.” Over the past 18+ months, we’ve seen that the right collaboration brings together unique capabilities to create unprecedented innovation. Collaboration in Action.

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Vaccines FDA 59

pharmaphorum

FEBRUARY 18, 2021

In late 2017, the FDA approved Admelog, Sanofi’s biosimilar of Humalog. 10 Since FDA approval in 1998 the ‘Little Blue Pill’ had some of the fastest prescription uptakes and sales growth of any medication, bringing in $400 million in revenue in its first quarter after launch and going on to produce annual sales of about $1.8

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Prescription Filling Compounding FDA Communication 52

PharmaShots

MARCH 9, 2023

She ranked 2nd on the “Most Powerful International Women” of Fortune Magazine 2019 edition Education: She holds a master’s degree in classics and modern languages from Oxford University Other Affiliations: Emma was appointed as Independent Director for Microsoft board in Dec’19. LinkedIn Total experience: 31 yrs.

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FDA Pharmaceutical Companies Pharmaceutical Companies Immunization 40

ISPE

OCTOBER 26, 2022

For example, an assessment for a facility primarily focused on US and EU markets would only consider GMPs and regulations from EudraLex and the FDA. FDA CFR Title 21 Parts 211, 600, and 1271; 8. , FDA Guidance for Industry: Sterile Drug Products Produced by Aseptic Processing–Current Good Manufacturing Practice, 11.

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Vaccines Compounding Documentation FDA 97

ISPE

OCTOBER 27, 2022

Since 2016, drug approvals per clinical campaign have outpaced the average across all modalities, resulting in 11 FDA-approved therapies in that span. A few innovators have shepherded this industry through these down years and managed to build impressive pipelines. Cell & Gene Therapy. Unlock Access to Member-Only Content. Company Name.

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Process Improvement Packaging Compounding Dosage 98

ISPE

JANUARY 9, 2023

Concepts of computerized software assurance (CSA) as discussed in the US FDA Center for Devices and Radiological Health (CDRH) Case for Quality program 1 are also explored and applied. The concepts of CSA related to US FDA CDRH Case for Quality program are also explored and applied where relevant. 1 US Food and Drug Administration.

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Documentation FDA Communication 52

ISPE

AUGUST 29, 2022

In May 2021, the US Food and Drug Administration (FDA) published a draft industry guidance, ICH Q12: Implementation Considerations for FDA-Regulated Products. The FDA has also offered both early dialogue and training to share knowledge and experience with the industry, providing an excellent example for other regulators to follow.

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Documentation FDA Communication Packaging 52

ISPE

MAY 9, 2023

Its Pharmaceutical Education & Research Center (PERC) is a US Food and Drug Administration (FDA)-registered, cGMP-compliant, single-source CRO equipped with the latest equipment and technologies, for most dosage forms, found in the pharmaceutical industry. Accessed 18 January 2023.

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Vaccines Pharmaceutical Companies Pharmaceutical Companies Medical Schools 94

ISPE

MAY 10, 2023

Each issue of Pharmaceutical Engineering magazine features thought-provoking content that is available to Members only, but NOW we're giving you exclusive access to see what you've been missing out on. SPuMoNI is particularly timely because blockchain has been proposed to become “a new digital service infrastructure” for Europe.

Chemotherapy 52

Chemotherapy Documentation Dosage Communication 52

ISPE

SEPTEMBER 11, 2023

m/s recommendation made its way into the US Food and Drug Administration (FDA)’s “Sterile Drug Products Produced by Aseptic Processing—Current Good Manufacturing Practice” 7 and into the EC GMP Annex 1 “Manufacture of Sterile Medicinal Products” in 2003. 5 , 6 From his research, the 0.45 8 When an air velocity of 0.45 At what velocity?

Documentation 52

Documentation FDA Packaging Communication 52

ISPE

MARCH 29, 2023

As part of the US Food and Drug Administration (FDA) QbD pilot 4 in 2005–2006, the need to convey how the control strategy is linked to the target product profile (TPP) and quality target product profile (QTPP) was discussed. Direct feedback from the US FDA on this pilot is shared in the discussion.

Documentation 52

Documentation Dosage Packaging Communication 52

ISPE

MARCH 29, 2023

As part of the US Food and Drug Administration (FDA) QbD pilot 4 in 2005–2006, the need to convey how the control strategy is linked to the target product profile (TPP) and quality target product profile (QTPP) was discussed. Direct feedback from the US FDA on this pilot is shared in the discussion.

Documentation 52

Documentation Dosage Packaging Communication 52

ISPE

AUGUST 30, 2022

Recent US FDA data show that the lack of raw material availability contributes to 27% of drug shortages (see Appendix ). It is considered a moderate change by the FDA (CBE30) and NMPA. This change ranges from a moderate change (CBE-30) by the FDA to a minor change not requiring prior approval by the WHO.

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Documentation FDA Packaging Communication 52

ISPE

MAY 9, 2023

21 Similarly, the FDA Center for Drug Evaluation and Research (CDER) began issuing electronic CPPs (eCPP) starting December 2021. Modernization of the FDA CDER Export Certificate Program.” As of 30 March 2020, EMA no longer provides printed certificates: only electronically signed and authenticated certificates will be issued.

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Documentation Packaging Pharmaceutical Companies Pharmaceutical Companies 52

ISPE

JANUARY 8, 2023

Building on these concepts, we provide insights and guidance on how to effectively support the “Human-AI-Team,” a term of the FDA 5 we believe describes very well the target operating model when interacting with AI: in a collaborative manner, complementing the strengths of cognitive as well as AI in GxP-related areas.

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Communication Documentation FDA 52

pharmaphorum

SEPTEMBER 1, 2020

George Merck on the cover of Time magazine. The FDA’s Frances O Kelsey: by blocking approval of Thalidomide in the US, Kelsey prevented thousands of children being born with life-changing deformities. Photo: FDA. Thalidomide and the development of drug safety regulation and monitoring.

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