Compliance Generic Drugs Marketing Medicine 
Pharmaceutical Technology
DECEMBER 15, 2022
On November 16, 2022, Medicines for Europe (MFE), the generics and biosimilars body, called for EU and national reforms to improve the security of medicine supplies, including tackling the impact of inflation on the security of essential medicine supplies with smart procurement guidelines for medicine.
FDA Law Blog
MARCH 6, 2024
Claud will be featured at the Legal, Regulatory, and Compliance Forum on Cosmetics & Personal Care Products in New York, NY. Prior to HP&M, John served 15 years at the Department of Justice, serving most recently as the Assistant Director of the Consumer Protection Branch, where he led the Corporate Compliance and Policy Unit.
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pharmaphorum
JULY 28, 2022
Logistical challenges of getting the right materials in the right place remain two years after the pandemic began, causing significant drug shortages to end-users. Businesses are facing challenges in obtaining raw ingredients for medicines. So, what can we do to insulate against the risk of shortages in these crucial generic drugs?
Camargo
NOVEMBER 11, 2020
When the FDA requires a product’s labeling to include a boxed warning (also called a “black box warning” because the text is surrounded by black border), the potential market value of the drug often drops severely. In 2019, Foundation Medicine and Bayer Healthcare Pharmaceuticals, Inc. Manager of Regulatory Compliance.
pharmaphorum
JUNE 3, 2021
The FDA approval of Alkermes’ new antipsychotic drug Lybalvi couldn’t have gone any better for the company, but it could still face a big challenge positioning the new drug in the highly genericised market. It has however been contraindicated in people taking opioids. In its favour?
Camargo
SEPTEMBER 8, 2021
The drugs approved via PANDAs are often used as the reference listed drug (RLD) for ANDAs under 505(j), and they can also be used as the listed drug for 505(b)(2) applications. PANDAs have historically been overseen by the FDA’s Office of Generic Drugs and thus regulated more like a generic than an NDA.
Cloudbyz
MARCH 5, 2024
In the intricate dance of drug discovery and development, two protagonists emerge as the cornerstones of modern medicine: biologics and small molecules. Administration and Dosage: Due to their nature, biologics are often administered via injection or infusion, which can affect patient compliance and convenience.
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