The FDA Law Blog

FEBRUARY 28, 2023

Lenz, Principal Medical Device Regulation Expert — Since 2005, 510(k) submissions have been formatted according to FDA guidance Format for Traditional and Abbreviated 510(k)s. Several sections of the eSTAR templates have questions that walk through related guidance documents. By Adrienne R. Know Your Guidances.

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European Pharmaceutical Review

JULY 4, 2024

2 The prerequisite to present statistically significant evidence for having efficacies of clinical relevance is crucial because FDA requires “adequate and well-controlled” multicentre clinical studies on any new drug candidate to document and support its safety and efficacy, and imposes the maximum level of scrutiny prior to approval.

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Omnicell

JANUARY 10, 2023

2005: HRSA publicly raised alarms against discriminatory reimbursement to 340B providers. The investigation, which included inquiries requesting large amounts of documents and communications from various stakeholders, is largely perceived as a drug industry-friendly fact-finding exercise.

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ISPE

JULY 21, 2023

The original ICH Q9 guidance was issued by ICH in November 2005, however, it was recognized in the ICH Q9(R1) Concept Paper that the benefits of QRM, as envisaged by ICH Q9, have not yet been fully realized. There is an increased emphasis in ICH Q9 (R1) on managing product availability risks related to manufacturing problems/issues.

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The Checkup by Singlecare

JUNE 7, 2023

This is one of the most well-documented apple cider vinegar benefits for men and women. One 2005 study found that tossing salmonella-contaminated arugula with a mixture of lemon juice and vinegar significantly reduced the bacteria. Apple cider vinegar might positively affect blood glucose levels when ingested regularly for a long time.

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European Pharmaceutical Review

DECEMBER 19, 2023

7 The additional substantial economic benefits that flow from room-temperature storability have also been thoroughly documented. This requires the development of technologies to rapidly produce effective, safe, stable vaccines that can be manufactured and distributed quickly. Maillard Reaction and Drug Stability. Woodhead Publishing.

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Pharmaceutical Technology

OCTOBER 5, 2022

These, along with other similar claims, meant Biogen owed potential damages of $1,036,900,151 to the US and the various States, as per court documents. In 2005, Biogen withdrew Tysabri from the market following a clinical trial that resulted in two participants contracting progressive multifocal leukoencephalopathy (PML).

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ISPE

MAY 11, 2023

Also, determining whether an intrusion occurred and documenting that intrusion adds to the challenges of performing aseptic technique properly (and perhaps adds to the subjectivity of the current control strategies). November 2005. Vials are rejected or discarded when critical zone intrusion is detected during operator interventions.

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Pharmaceutical Technology

OCTOBER 28, 2022

Quality by design (QbD) is a concept introduced into the pharmaceutical regulatory lexicon in 2005. QbD principles are woven into regulatory guidance documents, primarily guidances Q8 to Q11 of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH).

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The People's Pharmacy

MAY 8, 2023

There have been problems with records in the past: deceit, falsification of documents and even outright fraud. The FDA eventually determined that drug tests done at Cetero between 2005 and 2010 were untrustworthy. We know from investigating the FDA’s approval process ourselves that the honor system does not work.

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The Thyroid Pharmacist

MARCH 31, 2023

I had always been an outspoken, level-headed and calm person, but sometime in 2005, something called “new-onset anxiety” rocked my world. Anxiety was one of the most challenging and disempowering symptoms I experienced when I was first diagnosed with Hashimoto’s. I was scared. I couldn’t deal with life.

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Board Vitals - Pharmacist

JANUARY 6, 2023

A one-time requirement of six credits for cultural competence is to be completed in addition to the 100 hour requirement for physicians licensed before March 24, 2005. Of the 40 AMA PRA Category 1 Credits , 2 shall be related to End-of-Life care. These credits may be included if licensed after this date.

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ISPE

MAY 9, 2023

Improvements have been observed by various regulatory agencies in Latin America for the acceptance and implementation of international standards—for instance, the ICH Common Technical Document (CTD) format. Additional required information beyond ICH guidelines, or non-value-added documents (e.g., 6, and 2.3.S.7 7 are required.

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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

OCTOBER 26, 2022

Other industry best practices may not be formally documented in regulations or industry best practice guides, but should also be investigated as part of the assessment. Published March 2005. The assessment may also identify perception concerns. Biological (Viral and Microbial) Risk Progression. Published September 1978.

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European Pharmaceutical Review

JULY 13, 2023

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. 2005 Dec;146(7):913-5. Expert Review of Clinical Pharmacology. 2023 Mar 4;16(3):257-66. Mechoulam R. British journal of pharmacology.

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ISPE

SEPTEMBER 11, 2023

2 (1 May 2005). Subsequently, the new data is authored into Module 3 (Quality) of the Common Technical Document and submitted separately to multiple health authorities worldwide for approval. en/documents/regulatory-procedural-guideline/ema-regulatory-science-2025-strategic-reflection_en.pdf 66 a b DitaExchange. September 2004.

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ISPE

MARCH 7, 2023

Guideline on the Requirements to the Chemical and Pharmaceutical Quality Documentation Concerning Investigational Medicinal Products in Clinical Trials.” Published November 2005. Press Release. 30 November 2022. link] 6 European Medicines Agency. Committee for Medicinal Products for Human Use. 27 January 2022. link] 13 Beierle, J.,

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ISPE

AUGUST 30, 2022

The Common Technical Document (CTD) for the Registration of Pharmaceuticals For Human Use: Quality—M4Q guidance covers the minimum requirements for submission of raw materials; however, certain regions have additional requirements. The absence of any of the listed documentation should be scientifically justified.

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The Thyroid Pharmacist

JANUARY 20, 2023

Holy Basil ( Ocimum sanctum ) The anti-inflammatory effects of holy basil (also known as tulsi) have been documented in many in vitro and in vivo studies. Epub 2005 Oct 7; Costa CA, Tanimoto A, Quaglio AE, et al. Int J Ayurveda Res. 2010;1(1):37-40. doi:10.4103/0974-7788.59942 [57] Pinello KC, Fonseca Ede S, Akisue G, et al.

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The Thyroid Pharmacist

FEBRUARY 10, 2023

A few years ago, I had a few clients with documented elevations in prolactin, and I have seen that lowering prolactin levels can help with reducing thyroid antibodies. Studies have, however, documented that bromocriptine, a medication used to lower prolactin levels, can reduce flares in lupus, another autoimmune condition.

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The FDA Law Blog

NOVEMBER 11, 2024

Along with the proposed order, FDA issued as a supporting document the “ Scientific Review Supporting Proposed Administrative Order ” in which it describes the scientific data on the efficacy, pharmacology, and safety of oral PE underlying its determination to issue the proposed order. a); OTC Monograph M012: § M012.20.

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Pharmaceutical Technology

APRIL 27, 2023

Joe Makowiecki, business and product development leader for Enterprise Solutions at Cytiva, says the situation now reminds him of when single-use technology was in its nascency for monoclonal antibody (mAb) manufacture in 2005. “We There was a lot of cynicism and questions, like: ‘Why would you want to use single use?

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