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…audio, video, podcasts and interactive Web sites, biological recognition devices, and card readers.” In addition, electronic IC may use interactive computer-based technology, such as “diagrams, images, graphics, video technology and…
…the Federal Food, Drug, and Cosmetic Act and the Act of March 4, 1913) which is primarily manufactured using recombinant DNA, recombinant RNA, hybridoma technology, or other processes involving site…
…with Industry with respect to pre-GDUFA Year 3 Abbreviated New Drug Applications” (available on FDA’s Web site []). It will substantially expand our communications with applicants concerning pre-GDUFA backlog, GDUFA…
…of animal drug compounding, and two of the states (Florida and Kentucky) have been the site of adverse events related to compounded drugs over the past six years. For the…
…FDA’s web site. The three guidances listed above were not without controversy, particularly the recommendations relating to minimal manipulation. Many in industry had urged FDA to hold a public meeting…
…see, MYCHEL (ANDA 060851) had not been marketed for a while and Armenpharm wanted to submit a Prior Approval Supplement to FDA for an alternate manufacturing site as part of…
…all of the trial-related activities, such as administration of the investigational product, data collection, or safety monitoring, occur at locations other than traditional clinical trial sites. In a DCT, trial-related…
…heart disease, site specific cancers, diabetes, hypertension, osteoporosis, age-related macular degeneration, neural tube defects, and dental caries.” One of the principal objectives of the NRP was to develop a proposed…
…marketing material that is designed to mimic the look and feel of the host website. It is an increasingly popular means of promotion for marketers but, due to its nature,…
…also stipulate that a government-ordered closing of a site that occurs without prior notice may be an unforeseeable business circumstance. Id. On the other hand, the regulations state that “[t]he…
…early history of pharmacology. The site belonged to Louis Dufilho, reportedly America’s first licensed pharmacist, and includes exhibits on a wide range of products and practices common in 19th century…
…produced via aseptic processing. Id. at 3. And certainly much is alleged to have gone wrong at the European site inspected by FDA’s Team Biologics late last year. However, our…
…is recounted in the preamble to FDA’s new proposed rule. What are the features of the proposed rule? Those who are interested will, of course, want to read the entire…
…be made available on the FDA’s website, and will be transmitted by the Secretary of HHS to state agencies with responsibility for regulating compounding; Any drug product compounded in accordance…
…March 4, 1913) which is primarily manufactured using recombinant DNA, recombinant RNA, hybridoma technology, or other processes involving site specific genetic manipulation techniques) solely for uses reasonably related to the…