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Rare Diseases: Challenges and Control Measures

Rare diseases: Problems and Control Measures

UncategorizedJune 30, 20230Comments

Rare diseases, also known as orphan diseases, are medical ailments that impact fewer people in the community compared to other prevalent illnesses that often encountered in the population. Due to rare occurrences rare diseases are defined with respect to the prevalence found in the population and varies in the various geographic areas. In the United States,…

Counterfeit Medicines: A Widespread and Global Problem

Comparator DrugsJune 26, 20230Comments

Duplicate or fake medicines are called Counterfeits. Counterfeit medicines are purposely misrepresented in terms of their identification, source, or legitimacy. These duplicate medicinal products are manufactured and distributed on purpose to fool consumers by imitating real and genuine medical products. Both emerging and developed nations are home to fake medicines, which includes prescription drugs, over-the-counter drugs, and…

FDAs drug safety review process

UncategorizedJune 21, 20230Comments

Every discovery in the lab that shapes to be a drug takes various modes over several years before it appears from a lab to the medicine cabinet. A drug that is finally converted into a medicinal product is intended to address a particular ailment. In fact, a medicinal product is expected to either, prevent, treat, diagnose…

How to Dispose Unused Medicines and Expired Medicines?

UncategorizedJune 15, 20230Comments

Are you wondering what to do with the expired, unused, and old medicines lying in your medicine box? If you are throwing them in a normal household dustbin, please refrain. Most of our households have unused, expired, and old medicines at home and usually wonder what to do with them. Firstly, no one should consume old…

What is bolar provision in pharma Industry ? | The law

Bolar Provision: An Overview

UncategorizedJune 9, 20230Comments

Intellectual property rights grant the right holder a monopoly and market exclusivity for a stipulated few years. However, there are few exceptions where the right holder's monopoly is eroded and a third party can utilize the innovation for one or more legal purposes that do not come within the definition of infringement. A Bolar Provision…

Development and Drug approval process in Australia

Comparator DrugsJune 6, 20230Comments

The Therapeutic Goods Administration (TGA), a division of the Australian Government Department of Health, is in charge of regulating the process for the development and drug approval process in Australia. Prior to the sale of medicines in Australia, pharmaceuticals and other therapeutic items must first be approved by the TGA for their safety, quality, and…

Development and Approval of drugs in Brazil

Comparator DrugsJune 1, 20230Comments

Brazil is a huge pharmaceutical market that offers the pharmaceutical manufacturer fantastic potential. Registration of pharmaceuticals is a long procedure in Brazil involving various steps. In fact, it is an intricate procedure. It is not simple for pharmaceutical manufacturers to gain access to the Brazilian Regulatory Authority's marketing of medications and biologics. The Portuguese Agencia…

Drug development and drug approval process in Europe | Drug Manufacturers

Drug development and drug approval processes in Europe (EU)

Comparator DrugsMay 29, 20230Comments

Drug development and drug approval process in Europe is subject to stringent laws and guidelines to ensure that the drugs are safe, effective, and of high quality. Pharmaceuticals are evaluated and monitored in the European Union (EU) by the European Medicines Agency (EMA). To manufacture medications in Europe, a manufacturer must first get a manufacturing…

new drug development | Development and Approval of Drugs in the United States

Development and Approval of drugs in the United States (USA)

Comparator DrugsMay 25, 20230Comments

Novel and Innovative Drug Development involves several stakeholders and a talent pool from multiple and varied disciplines. It also involves partnering with various collaborators that fast-track new drug development processes and are equipped for quick turnaround timelines. It also involves discussing and seeking advice from the regulatory authorities that can help in the drug approval…

Procurement and Supply of Reference Listed Drugs (RLDs)

Reference Listed DrugsMay 19, 20230Comments

Reference Listed Drugs (RLDs), are approved innovator medicines. These branded medicines are the first introduction in the world market and serve as reference products. Reference products are the benchmark for generic drugs when it comes to quality, safety, and efficacy. The procurement and supply of RLDs typically involve the research-based innovator pharmaceutical companies that develop…

Comparator drug sourcing market: An overview

Comparator Drugs, Direct to Patient Services, Enteral Feeding Tubes, Generic drugs, IPR, Named Patient Program, Nasogastric Tube Feeding, pharmaceutical cold chain products, pharmaceutical companies, Reference Listed Drugs, UncategorizedMay 17, 20230Comments

The comparator drug sourcing market deals with exploring the availability and source of the comparator drug followed by its acquisition and supply. The reference or comparator drugs are required in conducting clinical trial studies that compare the efficacy and safety of the test formulation or an investigational new product to those of an existing approved reference product. These…

Cold chain solutions pertaining to cell and gene therapy drugs

Comparator Drugs, Direct to Patient Services, Enteral Feeding Tubes, Generic drugs, IPR, Named Patient Program, Nasogastric Tube Feeding, pharmaceutical cold chain products, pharmaceutical companies, Reference Listed Drugs, UncategorizedMay 13, 20230Comments

Cell and gene therapy belong to the field of biomedical research and is currently categorized as an experimental treatment. Both these therapies are targeted to treat, prevent, or potentially cure diseases that have no other treatment available. Their use is aimed to alleviate the underlying cause of genetic diseases and acquired diseases. Both cell and…