Recently, the FDA published three (03) guidance documents that focus on generic drug application submissions, labeling, and review. Among the three (03) guidance documents, two (02) are final drafts, and one (01) is a revised draft, which supports FDA’s Drug Competition Action Plan (DCAP) that was first announced in 2017.
- March 30, 2022 Generics
To ensure that cosmetics align with the latest quality and safety standards, markets across the globe have stringent Regulatory requirements. In markets such as the European Union, the United Kingdom, Malaysia, India, Saudi Arabia, etc., appointing a Legal Representative/Responsible Person (RP)/ Local Agent/License Holder is mandatory for local compliance.
- March 29, 2022 Pharmaceuticals, Health Authority Updates
After nearly two (02) decades of issuing the first draft guidance, the United States Food and Drug Administration (US FDA) finalized the guidance on population Pharmacokinetics (PK) in February 2022. The latest draft explains the application of population PK in drug development and recommendations on therapeutic individualization.
- March 29, 2022 Pharmaceuticals, Market Access
Emergency Use Authorizations (EUAs) are significant in making life-saving medicinal products available to patients faster. They have been helpful in dealing with pandemics like COVID-19. An initiative of the United States Food and Drug Administration (USFDA) started in the year 2004, and the EUA came into force when Section 564 of the Federal Food, Drug, and Cosmetic Act was amended by the Project BioShield Act.
- March 28, 2022 Pharmaceuticals
Currently, the European clinical trials environment is quite challenging. The COVID-19 pandemic has shown a relative absence of EU impactful, multi-state trials. In addition, the disharmony of Regulatory requirements between the Member States has complicated the submission of multi-state trial applications.
- March 28, 2022 Biologicals
To promote global convergence among the Health Authorities and encourage the Member States to strengthen their Regulatory system on Cell and Gene Therapy products regulations, the WHO (World Health Organization) proposed a risk-based framework for regulating Cell and Gene Therapy Products (CGTPs).
- March 16, 2022 Medical Devices
The Swiss Mutual Recognition Agreement (MRA) for medical devices between the EU and Switzerland has lapsed on May 26, 2021, and the negotiations between Switzerland and the EU have concluded without any concurrence on Institutional Agreement (InstA).
- March 8, 2022 Regulatory Software & Services, Health Authority Updates
In addition to completing the requisite xEVMPD data submissions, life sciences organizations will now need to use a web-based application form called the Digital Application Dataset Integration (DADI). The European Medicines Agency (EMA) designed DADI as a long-term replacement for the PDF-based electronic Application Form (eAF), which was incepted to support eCTD submissions.
- March 1, 2022 Pharmaceuticals, Regulatory Labeling
A pharmaceutical label is a monologue between the drug manufacturer and the patients. Miscommunication of any kind can affect the end-user. To protect the interest of the patient population, global Health Authorities (HAs) closely monitor pharmaceutical labels and indications of pre-approval. There are various components to a label and with each additional component, the chances of errors increase gradually.
- February 24, 2022 Cosmetics Regulatory Services, Regulatory Affairs
Hair colorants are classified as cosmetic products by the European Commission (EC) and are regulated under the regulation (EC) No: 1223/2009. Hair colorants contain a mixture of substances called hair dyes that are used to change the color of hair or to restore the original hair color. They are classified into the following three (03) categories based on their color fastness: