Regulatory Documents - Pharma

Relevant Publications

Harmonized Database of Western U.S. Water Rights (HarDWR) v.1.

Issue Release: 2024

Methodological guidelines and publications of benefit-risk assessment for health technology assessment: a scoping review.

Issue Release: 2024

Overdosage Section in US and EU Labeling.

Issue Release: 2024

Socio-environmental externalities of sewage waste management.

Issue Release: 2024

Assessing human carcinogenicity risk of agrochemicals without the rodent cancer bioassay.

Issue Release: 2024

Role of remediation in cases of serious misconduct before UK healthcare regulators: a qualitative study.

Issue Release: 2024

Soil legislation and policies: Bibliometric analysis, systematic review and quantitative approaches with an emphasis on the specific cases of the European Union and Portugal.

Issue Release: 2024

Evolution of blockchain accounting literature from the perspective of CiteSpace (2013-2023).

Issue Release: 2024

Genetic counselling legislation and practice in cancer in EU Member States.

Issue Release: 2024

A missed opportunity for public health: How impact assessment shaped EU rules on the marketing of unhealthy commodities to children.

Issue Release: 2024

Tobacco industry strategies to influence the regulation of new and emerging tobacco and nicotine products in Latin America and the Caribbean.

Issue Release: 2024

Algorithmic discrimination: examining its types and regulatory measures with emphasis on US legal practices.

Issue Release: 2024

Approaches and experiences implementing remote, electronic consent at the Leeds Clinical Trials Research Unit.

Issue Release: 2024

Text summarization with ChatGPT for drug labeling documents.

Issue Release: 2024

REACHing for divergence?-UK chemical regulation post-Brexit.

Issue Release: 2024

OHDSI-compliance: a set of document templates facilitating the implementation and operation of a software stack for real-world evidence generation.

Issue Release: 2024

Rodent anogenital distance recommendations.

Issue Release: 2024

The Biosimilar Revolution: Assessing the European Union\'s Approach to Biosimilarity, Interchangeability, Patient Access, and Its Market Analysis.

Issue Release: 2024

Biosimilar approval pathways: comparing the roles of five medicines regulators.

Issue Release: 2024

[Integration of Inventory Data from Cohort and Registry Studies into an Existing Research Network: National Pandemic Cohort Network (NAPKON)].

Issue Release: 2024

How are New Drugs Discovered?

What Causes Adverse Drug Events?

What are the Key Challenges?

How Does Cellular Stress Impact Drug Development?

What are the Implications for Pharma Companies?

What are the Key Cellular Stress Pathways?

How Does Pharma Play a Role in Chronic Conditions?

How Can Technology Aid in Patient Education?

What are the Phases of Clinical Trials?

How Does the Patent System Affect Generic Competition?

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