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Drug shortages, patent tussles, and gripes about the Inflation Reduction Act (IRA) headlined the conversation at an FDA “check-up” meeting conducted by the House Energy and Commerce’s subcommittee on health. Read More
One of the biggest mistakes companies make in their responses to the FDA’s inspection observations is to focus on the specific issues raised without looking at the bigger picture, according to one regulatory compliance expert. Read More
NIH is seeking comments on a new policy that would require partnering organizations who receive institute funding to submit a plan outlining steps they will take — through a patent licensing agreement — to promote patient access to any resulting drug, biologic, vaccine or device. Read More
Magellan Diagnostics has agreed to plead guilty and pay $42 million for concealing a device malfunction for years that produced inaccurately low lead test results for potentially tens of thousands of children and other patients, including pregnant women. Read More
Akan Biosciences, the manufacturer of a sterile injectable biologic product, received an FDA Warning Letter for failing to properly test donor tissue samples for communicable diseases and failing to have an approved BLA. Read More
Congress needs to put more pressure on agencies like the FDA and the US Patent and Trademark Office (USPTO) to collaborate on fighting patent thickets, the multiple patents pharmaceutical companies file after a drug is already on the market to extend the drug’s period of exclusivity and keep generic alternatives off the market. Read More
Without strong economic incentives, the current antibiotic development pipeline won’t keep pace with burgeoning rates of antibiotic resistance, according to a new study by the International Federation of Pharmaceutical Manufacturers and Associations (IFPMA). Read More
This edition of Quick Notes features announcements of Takeda, Abbvie and Novo Nordisk drug development collaborations and J&J’s acquisition of Proteologix. Read More
The FDA has a lot of work to do to regain trust among a wide swath of demographic groups — starting with women — according to a recent survey. Read More
In an analysis that seeks to help frame the discussion at the upcoming Pediatric Oncology Subcommittee of the Oncologic Drugs Advisory Committee, the FDA says that a law enacted in 2017 has increased the number of planned studies to test drugs for pediatric cancers compared to earlier regulatory laws. Read More
Joining three other Eugia Pharma plants in India, the company’s facility in Bhiwadi, Rajasthan, was handed a Form 483 from the FDA, citing observations of operators not following procedures in place to prevent microbial contamination of drug products, among other lapses. Read More
Wayne Pines, senior director at APCO Worldwide, a former associate commissioner of the FDA, and a member of the FDAnews Editorial Board, reviews the landscape for the “clear, conspicuous and neutral” manner now required for direct-to-consumer marketing of drugs and devices. Read More