Pharmaceutical Technology

JANUARY 6, 2023

The agreement outlined that Par would keep its generic equivalent off the market for as many as two years, delaying the generic launch till September 30, 2014. In September, Novartis sent the FDA a petition, after a similar one was rejected in April 2021, asking for Entresto’s patent protection to be extended to February 2024.

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European Pharmaceutical Review

JULY 4, 2024

In the US, botanical dietary supplements can be sold without US Food and Drug Administration (FDA) approval, 1 prompting many vendors to promote the use of botanical products as dietary supplements , 2 rather than pursue a path of regulatory approval. 3 Is two too few? 3 Is two too few?

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Pharmaceutical Technology

MARCH 30, 2023

Broadening uses and secured full approvals Since its first approval in September 2014, Keytruda has achieved blockbuster status on the market. Earlier in March, the FDA shared a draft guidance on how to run clinical trials for the accelerated approval of cancer drugs.

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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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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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The FDA Law Blog

FEBRUARY 29, 2024

156, as added by the 1984 Hatch-Waxman Amendments, for certain FDA-regulated products. The use of a surrogate endpoint can considerably shorten the time required prior to receiving FDA approval. If the confirmatory trial shows that the drug actually provides a clinical benefit, then the FDA grants traditional approval for the drug.

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pharmaphorum

DECEMBER 29, 2022

The case revolves around allegations that Novartis made an agreement in 2011 with Par Pharmaceutical when Exforge (valsartan/amlodipine) was nearing the end of its patent life that was designed to keep Par’s generic version of the drug off the market until 30 September, 2014.

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European Pharmaceutical Review

JULY 13, 2023

It is estimated that only one in 10 drugs that enter Phase I trials are subsequently licensed by the US Food and Drug Administration (FDA). 5 When these medicines are prescribed to patients, we can use feedback from the real-world data that documents clinical outcomes, efficacy measures, patient-reported outcomes, and adverse events.

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Pharmaceutical Technology

OCTOBER 5, 2022

Between 2009 and 2014, the time period of Biogen’s alleged misconduct, the standard of care for MS involved the use of Biogen’s immunomodulatory drugs such as Avonex (Interferon beta-1a), Tecfidera (dimethyl fumarate), and Tysabri (natalizumab). 4 integrins, which play a key role in MS pathology.

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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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ISPE

MARCH 29, 2023

Concept Paper: M4Q(R2) Common Technical Document on Quality Guideline.” 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. The authors propose using Module 2.3

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ISPE

MARCH 29, 2023

Concept Paper: M4Q(R2) Common Technical Document on Quality Guideline.” 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. The authors propose using Module 2.3

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ISPE

JANUARY 11, 2023

August 2014. 5 It includes cleaning validation master plan, product risk assessment, utility and equipment readiness, analytical method readiness, sampling site selection/grouping, standard operating procedures, validation protocols, execution of validation protocols, personnel training, and the validation documentation package.

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ISPE

SEPTEMBER 8, 2023

USA The FDA established the Emerging Technology Program (ETP) in 2014 and has actively promoted the program 8. In his keynote presentation at the 2022 ISPE Annual Meeting & Expo in Orlando, FL, Dr. Michael Kopcha, Director of the Office of Pharmaceutical Quality, emphasized the FDA’s commitment to promoting advanced manufacturing.

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PharmTech

JUNE 6, 2025

While the document itself is a quarter of a century old at this point, it is laid out in such a way that relevancy is maintained. This guideline forms the key document referenced by regulatory authority documents that detail structural characterization requirements of biopharmaceuticals.

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PharmTech

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. The secondary label will specify the Drug ZA-ion amount per capsule and the equivalent Drug Z-salt amount consistent with FDA labeling guidance.

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ISPE

AUGUST 29, 2022

For changes requiring approval before implementation, once the necessary information has been submitted across regions, each health authority must review the data package and documentation based on local requirements. laboratory notebooks, batch records, and technical reports) to submission documents (e.g.,

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ISPE

JULY 5, 2023

In 2014, CDER established the Emerging Technology Program (ETP) within its Office of Pharmaceutical Quality to better facilitate the adoption of emerging technologies such as CM. 13 An FDA-authored paper indicating support for the implementation of CM using science- and risk-based approaches followed soon thereafter.

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The FDA Law Blog

JANUARY 23, 2023

Livornese — Last month, Congress took a big step towards improving clinical trial diversity by requiring sponsors of most drug and device clinical studies to submit a diversity action plan when they submit key trial documents to the Food and Drug Administration (FDA). This guidance was finalized in 2020. by the end of 2023).

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The Thyroid Pharmacist

JULY 14, 2023

10] I initially wrote a guide on LLLT for my clients in my Hashimoto’s Self-Management Program in 2014, before the follow-up study was done, and was concerned that the effects wouldn’t last. All Lumebox products are FDA-registered, follow the Good Manufacturing Practice (GMP) system, and every batch is third-party tested.

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The FDA Law Blog

JANUARY 7, 2024

A review of FDA’s Postmarketing Requirements and Commitments database reveals that one of the most common reasons FDA requires postmarketing studies is to assess the impact of a drug on maternal and fetal outcomes when taken by pregnant women. For post-approval pregnancy studies, it most certainly does.

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The Checkup by Singlecare

JUNE 14, 2024

Additionally, a 2014 review of studies points to evidence that people with NAFLD are more likely to be deficient in vitamin C, leaving them more prone to inflammation and oxidative stress. Food & Drug Administration (FDA) like prescription drugs. It’s important to remember that herbal supplements aren’t regulated by the U.S.

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ISPE

OCTOBER 27, 2022

In December 2021, the US FDA issued a cross-center draft guidance with recommendations on the use of digital health technology tools (DHTTs) to acquire data remotely from participants in clinical investigations for medical products. Table 3: Example classification of DHTs. .

Health and Personal Care Stores 52

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ISPE

OCTOBER 27, 2022

In December 2021, the US FDA issued a cross-center draft guidance with recommendations on the use of digital health technology tools (DHTTs) to acquire data remotely from participants in clinical investigations for medical products. Table 3: Example classification of DHTs. .

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ISPE

OCTOBER 28, 2022

The writing of requirements, design documentation, and test scripts, and the configuration of hardware and software, can be conducted from home. During the COVID-19 pandemic, the US FDA issued guidelines for remote evaluations of drug manufacturing and bioresearch facilities. Los Angeles, CA, US: Sage Publications, 2014.

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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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ISPE

SEPTEMBER 11, 2023

FDA Official Warns Manufacturers of Common Problems Found in Aseptic Operations.” www.raps.org/news-and-articles/news-articles/2023/3/fda-official-warns-manufacturers-of-common-problem 25 US Food and Drug Administration Center for Drug Evaluation and Research. September 2014. September 2022. 7 March 2023. Regulatory Focus.

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The Thyroid Pharmacist

JULY 29, 2022

Back in 2014, I found that my Hashimoto’s flared up after using a particular lip gloss; once tested, it came back as containing arsenic! . This article of mine discusses 19 thyroid-toxic products that have been banned by the FDA. Feel free to use my own health timeline as a guideline to document your health journey.

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ISPE

JULY 6, 2023

As of 2022, there were 15 drugs (see Table 1) manufactured using CM elements that have received FDA approval, with GSK, Pfizer, and Vertex owning approximately 60% of the market share, followed by Janssen/J&J with about 13%. Table 1: List of FDA-approved commercial products using CM elements.

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STAT

FEBRUARY 9, 2024

Surgeon General Luther Terry’s landmark Report, “ Smoking and Health ,” which definitively documented the causal link between smoking, disease, and death. Tobacco control policies implemented between 1964 and 2014  saved  8 million lives in the United States. In

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The FDA Law Blog

JANUARY 30, 2025

FDAs withdrawal authority when a confirmatory trial is not conducted with due diligence was expanded to include that FDA could specify the conditions for a postapproval study. Considering FDAs new authority to specify the conditions for such confirmatory trials (e.g.,

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Viseven

JANUARY 24, 2025

Change control process requirements vary between companies and regions, but here is a list of the most common ones to give you a general idea: EU 1252/2014 This is a guideline for companies operating in the European Union and dealing with active substances. FDA 21 CFR Part 211 This regulation governs the practices of U.S.

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The Thyroid Pharmacist

JANUARY 20, 2023

In 1998, the Food and Drug Administration (FDA) defined an adaptogen as a new kind of metabolic regulator that has been proven to help in environmental adaptation and to prevent external harms. 2014 Apr;5(4):635-44. [12] Published 2014 Dec 18. Published 2014 Aug 15 [35] Gao Y, Wei Y, Wang Y, Gao F, Chen Z. Food Funct.

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The FDA Law Blog

MAY 26, 2025

The gray box at the top of the document at this link shows the change in position. 149, 158 (2014). And the memo goes one step more arguing that, even if otherwise truthful, promotion of off-label uses of hormones can run afoul of FDA prohibitions on misbranding and mislabeling. Anthony List v. Driehaus , 573 U.S.

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