Pharmaceutical Technology
JULY 15, 2022
Insulin prices made the headlines again as California governor Gavin Newsom announced plans on 7 July for the state to manufacture low-cost insulin. The state plans to work directly with a contract manufacturing organization (CMO) to manufacture low-cost insulin. In-house manufacturing the norm.
FDA Law Blog
SEPTEMBER 6, 2023
Food and Drug Administration – labeled an “Official Action Indicated” classification – is generally devastating for the facility, not least because it can stall FDA approval of applications to market drugs manufactured at the facility.
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Pharmacy Checkers
MAY 22, 2020
One of our more popular Ask PharmacyChecker posts is called “ How can I determine where a drug is manufactured? ” But here’s something different to chew on: Even drugs that our research categorized as manufactured in the U.S. has the pharmaceutical ingredients it needs to make drugs that treat people with Covid-19.
World of DTC Marketing
APRIL 12, 2021
The US Food and Drug Administration (FDA) believes the adulteration of heparin was an economically motivated act—a clear breach of the US pharmaceutical supply chain. Ironically, in later times, the intense competition for out-of-patent drugs has subsided, which has led to spiraling rises in generic drug prices and shortages.
Pharmaceutical Technology
NOVEMBER 21, 2022
Other contributing factors include the decreasing number of post-market studies and difficulties in primary research and manufacturing. A lower number of clinical trials and regulatory filings were other important influences behind the decision.
Camargo
OCTOBER 14, 2021
The pilot program is the first step in allowing manufacturers to receive a preliminary review of a novel excipient, prior to drug product formulation. Eligibility for the pilot program has been limited to excipients that 1) have not been previously used in FDA-approved drug products, and 2) do not have an established use in food.
Pharmaceutical Technology
NOVEMBER 21, 2022
Other contributing factors include the decreasing number of post-market studies and difficulties in primary research and manufacturing. A lower number of clinical trials and regulatory filings were other important influences behind the decision.
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