The FDA Law Blog

DECEMBER 4, 2023

12, 2012). “[W]hen the circumstances surrounding the presentation of a prescription would give rise to suspicion in a ‘reasonable professional,’ there is a duty to question the prescription.” The CDC has advised clinicians to carefully assess increasing total opioid dosage to greater than 50 MMEs per day). Holiday CVS, L.L.C.

Controlled Substances 139

Controlled Substances Documentation Dosage Prescription Filling 139

ISPE

OCTOBER 28, 2022

Annex 1 Implementation: The first question from the audience was referred to Paul Gustafson as it related to the implementation periods of 1 year for most of Annex 1 and 2 years for section 8.123 on lyophilizers (which Paul had mentioned in his presentation before the Panel Discussion).

FDA 97

FDA Vaccines Dosage Documentation 97

The Thyroid Pharmacist

JUNE 16, 2023

Black seed oil has likely been used as a medicinal herb for 3000 years or more, and its use has been documented in Ayurveda, Unani, Tibb, Siddha, and other systems of medicine. [4] The trial used dosages of 1, 2 and 3 grams of black seed oil per day, and found that the 2 gram per day dose was the most effective.

Dosage 111

Dosage Compounding Immunization Insurance 111

ISPE

NOVEMBER 21, 2022

It was usual practice for TGA to prepare additional guidance/explanatory documents for industry and for TGA inspection staff to participate in training seminars to assist industry. This is an informal synopsis of presentation made at the ISPE Singapore Affiliate Conference in Singapore on 18 August 2022. Disclaimer. Regulatory.

FDA 52

FDA Vaccines Dosage Documentation 52

ISPE

JULY 6, 2023

1 Although CM technology has been around for decades, it does present some novel challenges to the pharmaceutical industry, especially when the goal is to supply therapeutics globally. Q13 Training Materials Although the guidance document has been completed and was endorsed in January 2023, the work is not yet done.

Documentation 52

Documentation Dosage FDA Pharmaceutical Companies 52

ISPE

OCTOBER 27, 2022

Blow-fill-seal containers are commonly used for various dosage forms, what are the latest developments in this field? Most importantly, the panellists have actively been involved in the commenting process via ISPE and other organizations and can give background information on the document and it’s interpretation.

Dosage 98

Dosage Vaccines FDA Documentation 98

The Thyroid Pharmacist

JULY 14, 2023

2] In some cases, the person will become hyperthyroid, and the dosage of their medications will need to be reduced. If they are already taking thyroid medications, they may find themselves overmedicated, and may need to work with their doctors to reduce their dosage of thyroid medications. References [1] Nanan R, Wall JR. Ross, DS.

Dosage 97

Dosage FDA Immunization Documentation 97

IDStewardship

AUGUST 29, 2022

Therefore, prioritizing your assessment of patients with an imminent discharge time ( e.g. , reconciling medication discrepancies with their medications on admission and transfer; reviewing indications, efficacy, safety, dosage, and adherence of all medications prescribed) can significantly improve patient outcomes. .

Hospitals 130

Hospitals Dosage Documentation Compounding 130

European Pharmaceutical Review

NOVEMBER 24, 2022

Tackling pharmaceutical counterfeiting continues, therefore, to be a clear and present priority for manufacturers, healthcare authorities and law enforcement. One area in which the problem can be tackled effectively is product packaging. Blister packs can also benefit from anticounterfeiting holography.

Packaging 95

Packaging Labelling Documentation Dosage 95

The Thyroid Pharmacist

MARCH 31, 2023

You may want to read my articles on understanding your thyroid labs and taking thyroid medications for more information on how adjusting thyroid medication dosages can help optimize your thyroid hormone levels. Practice Mindfulness Mindfulness is a term used to describe being conscious and aware of the present moment. Front Psychol.

Immunization 105

Immunization Dosage Documentation 105

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.

Documentation 52

Documentation Packaging Pharmaceutical Companies Pharmaceutical Companies 52

ISPE

JULY 6, 2023

For much of the pharmaceutical industry, batch manufacturing (BM) processes that have been relied upon for decades remain the preferred approach for most oral solid dosage (OSD) drug products. This document catalogs and summarizes the various risks to the company. Figure 3 presents a 5 × 5 matrix for assigning final overall ratings.

Insurance 52

Insurance Documentation Pharmaceutical Companies Pharmaceutical Companies 52

ISPE

MARCH 29, 2023

Concept Paper: M4Q(R2) Common Technical Document on Quality Guideline.” This article summarizes an alternate and more functional way to format the QOS presented in Module 2.3. The authors propose using Module 2.3 3 1 International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use.

Documentation 52

Documentation Dosage Packaging Communication 52

ISPE

MARCH 29, 2023

Concept Paper: M4Q(R2) Common Technical Document on Quality Guideline.” This article summarizes an alternate and more functional way to format the QOS presented in Module 2.3. The authors propose using Module 2.3 3 1 International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use.

Documentation 52

Documentation Dosage Packaging Communication 52

ISPE

SEPTEMBER 11, 2023

This article presents relevant insights on the current regulatory and technical landscape for decentralized manufacturing, with select examples of current applications, and discusses perspectives on evolving and adapting the current regulations to meet future capabilities. Journal of Biotechnology 213 (2015):120–30. doi:10.1016/j.jbiotec.2015.06.388

Health and Personal Care Stores 52

Health and Personal Care Stores Vaccines Packaging Documentation 52

ISPE

AUGUST 30, 2022

Case studies are presented that demonstrate the importance of defining the raw material attributes that are critical to product quality and how this could support increased postapproval flexibility (including the use of ICH Q12 principles). and the impact on supply resiliency. Additional requirements are described in ICH Q7.

Documentation 52

Documentation FDA Packaging Communication 52

ISPE

JULY 6, 2023

Going up in scale, in a CONTINUUS Pharmaceuticals and MIT collaboration, an end-to-end, QbD-driven integrated continuous manufacturing (ICM) pilot plant 8 was designed to produce both small molecule active pharmaceutical ingredient (API) and oral solid dosages. Deep Learning for Continuous Manufacturing of Pharmaceutical Solid Dosage Form.”

HIV Treatment and Prevention Agents 52

HIV Treatment and Prevention Agents Dosage Pharmaceutical Companies Pharmaceutical Companies 52

ISPE

SEPTEMBER 8, 2023

Results will be presented at meetings, summarized in blogs, and eventually issued in a report. 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. 22 June 2023.

FDA 52

FDA Dosage Documentation Communication 52

ISPE

MAY 10, 2023

Although the pharmaceutical industry has consistently improved manufacturing processes 3 in compliance with good manufacturing practices, 4 there are documented deviations from good practices 5 including the continued falsification of medicines. 6 (Note: The terms “pharmaceutical” and “pharma” interchangeably employ throughout this article.)

Dosage 52

Dosage Chemotherapy Documentation Labelling 52

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.

Dosage 83

Dosage Documentation FDA Labelling 83

The Thyroid Pharmacist

JANUARY 20, 2023

When doctors examined her three months after this event, they observed moderate Hashitoxicosis (transient Hashimoto’s) which presented as fatigue and palpitations. Some individuals may be sensitive to anthraquinone compounds, which are present in aloe latex (taken from the outer skin of the plant) and aloe whole leaf extracts.

HIV Treatment and Prevention Agents 90

HIV Treatment and Prevention Agents Immunization Compounding Dosage 90