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Manufacturers must submit all NDA, ANDAs, BLAs and drug master files electronically by May 15, 2017, and all commercial INDs one year later, under an FDA final guidance. Read More
Sponsors of INDs, NDAs, ANDAs and supplemental applications for drugs that are highly soluble in water but not easily absorbed through the intestines can now request waivers of studies proving the drug has a systemic effect or is equivalent to a reference product. Read More
The International Society for Pharmaceutical Engineering is developing a tool to help manufacturers locate gaps in production and quality systems, with the aim of averting shortages in the international drug supply. Read More
Particulates have forced yet another drugmaker — this time Teva — to recall an injectable. The drugmaker voluntarily recalled eight lots of its anticancer therapy Adrucil after a combination of silicone rubber from a filling diaphragm and fluorouracil crystals was found in vials. Read More
Actavis’ $68 billion acquisition of Allergan drove a record-setting $166.3 billion in pharma deals closed during the first quarter of 2015, a new report from PricewaterhouseCoopers shows. Read More
The FDA is not requiring ordinary proof of effectiveness as it strives to approve orphan drugs for some 7,000 diseases, only 300 of which currently have treatment options, a new study concludes. Read More
The FDA has granted British drug giant GlaxoSmithKline an asthma indication for another drug meant to be used with its Ellipta dry powder inhaler. Read More
Between 2013 and 2014, the European Medicines Agency nearly doubled, to 40 percent, the percentage of drug adverse event assessments that led to a recommendation for updated patient information on labeling, a new report says. Read More
Sponsors seeking Canadian approval of new drugs or indications based on published literature or postmarketing data need to be able to prove that their drug is comparable to its reference product, Health Canada says. Read More
The FDA is offering two grants of up to $600,000 each over three years in exchange for data to establish statistically based pharmaceutical quality standards — a further sign of the agency’s commitment to using quality metrics. Read More