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The FDA is set to release a slew of product-specific guidances to help generic manufacturers demonstrate the bioequivalence between their proposed generic and the reference product. Read More
HHS has issued a new variation of its recently invalidated rule requiring drugmakers to offer discounts on orphan drugs sold to hospitals that serve the poor when the products are meant for non-rare conditions. Read More
Indian regulators are seeking information from six manufacturers of generic cancer drugs in preparation for setting price caps on the products, a move that one industry observer says was expected. Read More
The U.S. Food and Drug Administration and Customs and Border Protection are accepting applications for an 18-month pilot of a “trusted trader” program. The initiative aims to reduce inspections and oversight of products imported from manufacturers that establish tough internal import control programs of their own. Read More
The FDA has been asked to turn over a trove of information related to the development of its proposed generic drug labeling rule, with GOP leaders of a key House investigative committee claiming the agency engaged in “dubious” behaviors in the rulemaking process. Read More
Starting statin therapy earlier in people with lower risks of cardiovascular disease (CVD) could save thousands of lives and billions of dollars annually, according to guidance issued Friday from the UK’s healthcare costs regulator. Read More
Manufacturers reporting adverse events suspected to be caused by vaccines should submit their individual case safety reports via the agency’s electronic submissions gateway in XML format, says a new draft guidance that completely overhauls a 1998 predecessor. Read More
The FDA intends to step up its scrutiny of a company’s data integrity protections during manufacturing inspections, following a series of investigations that caught drugmakers backdating manufacturing records and falsifying data. Read More
The FDA has slapped a warning on an Italian active pharmaceutical ingredient manufacturer for deleting quality data, the latest indication the agency is serious about clamping down on poor manufacturing data integrity. Read More
The FDA this week approved the first human recombinant C1-esterase inhibitor product for adolescents and adults with acute attacks of a rare condition called hereditary angioedema (HAE). Read More
Starting next year, drugmakers in Canada will need to submit for premarket review information on proposed drug names, labels and packages under amended regulations that aim to ensure drug labeling is clear and easy to understand and a drug can’t be confused with another product. Read More