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Radical Transparency or Radical Redundancy? FDA Publishes 200+ Complete Response Letters, Most of Which Are Already Public

The FDA Law Blog

However, the vast majority of the CRLs posted in the openFDA database are already available in the action packages posted on FDA’s Drugs@FDA database and approved biologics product pages. Greater transparency into our decisions will help align expectations and foster better communication among stakeholders.”

FDA
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EpiPen patent expiry opens new era for innovation

Pharmaceutical Technology

Mylan acquired the rights to the injector pen for treating anaphylactic reactions following the $6.7bn acquisition of Merck KGaA’s generics business, Merck Generics, in 2007. Go deeper with GlobalData Reports NPVM: Epipen Data Insights The gold standard of business intelligence.

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The European Market Access Lag: 2021–2024

Pharmaceutical Technology

For example, Recordati’s Cystadane (betaine) was centrally approved in 2007 but did not see its first reimbursement in Poland until 2023. In Romania, Novartis’s Atriance (nelarabine) was also centrally approved in 2007 but did not receive its first reimbursement in Romania until 2021.

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What to Keep in Your Integrative Medicine Cabinet

The Thyroid Pharmacist

Follow package instructions. These signals create communication and function within nerves and muscles, as the electrolytes move in or out of cells. Follow package directions for each supplement. The herb itself can be poisonous if ingested. They’re great for injuries, overuse, or soreness from workouts.

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Contamination Trends & Proposed Solutions

ISPE

The cases covered the same types of contaminants and impurities noted in Table 1: microbial contaminants, process-related im-purities, metal contaminants, packaging-related contaminants, drug cross-contamination, and an “unknown” category encompassing other contaminants associated with the manufacturing process, including those from cell culturing.