Under the Hatch-Waxman Act, every generic candidate has to give the holder of the approved New Drug Application (NDA) notice of the filing of the ANDA. As soon as they receive it, in turn it files a patent infringement lawsuit...
Read MoreIn order to assure that a company has a well functioning organizational structure executive management needs to be very proactive. No where is this more the case than in the QC laboratory environment. Audits and warning letters...
Read MoreNot too long ago, a bipartisan group of senators in the United States introduced legislation that could spell big problems for the pharmaceutical industry. The “Pharmaceutical Market Access and Drug Safety Act” is a piece of...
Read MoreNo matter what happens with the biosimilar legislation, patent holders will have to go through their patent files carefully. The current generic drug industry was born from the Hatch-Waxman Act of 1984. Among its creations,...
Read MoreThe biotech and pharmaceutical industries face new changes with proposed rules concerning cGMP (current good manufacturing practice) for combination products. The cGMP proposal (74 Fed. Reg. 48,423) by the FDA’s Office of...
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