Nanofibers: A current era in drug delivery system

Nanofibers have a large area of surface variable 3D topography, porosity, and adaptable surface functions. Several researchers are researching nanofiber technology as a potential solution to the current problems in several fields. It manages cardiovascular disorders, infectious diseases, gastrointestinal tract-associated diseases, neurodegenerative diseases, pain treatment, contraception, and wound healing. The nanofibers are fabricated using various fabrication techniques, such as electrospinning, phase separation, physical Fabrication, and chemical fabrication. Depending on their intended use, nanofibers are manufactured using a variety of polymers. It comprises natural polymers, semi-synthetic polymers, synthetic polymers, metals, metal oxides, ceramics, carbon, nonporous materials, mesoporous materials, hollow structures, core-shell structures, biocomponents, and multi-component materials. Nanofiber composites are a good alternative for targeted gene delivery, protein and peptide delivery, and growth factor delivery. Thus, nanofibers have huge potential in drug delivery, which enables them to be used for various applications and can revolutionize these therapeutic areas. This review systematically studied nanofibers' history, advantages, disadvantages, types, and polymers used in nanofiber technology. Further, polymers and their types used in the preparation of nanofibers were summarised. Mainly review article focuses on the fabrication method, i.e., electrospinning and its types. Finally, the article discussed the applications and recent advancements of nanofabrication technology

Pre-submission facility correspondence for generic dosage form with an expedited-approval in 8 months

PFC (Pre-Submission Facility Correspondence) is the initial submission for an ANDA (Abbreviated New Drug Application), comprising information for the application similar to the original ANDA, and only valid in the United States Agency For a pre-determined inspection of the finished drug product's facility information. The Applicant can be introducing their Drug Product into the Market before the ANDA's Goal date of 8 months, according to the Pre-Submission Facility Correspondence. The submission type Original ANDA, PAS (Prior approval supplement), and PAS Amendment is based on prior review goal submission. The FDA (Food and Drug Administration) approves PFC submission for a range of reasons, including drug product shortfalls, COVID-19 emergency dosage medication, Patent paragraph-IV (patent is invalid or will not be infringed), and market-availability of one RLD (Reference listed drug) and one generic. The complete submission process gone through the eCTD submission format from the ESG (Electronic Submission Gateway)