FDA Law Blog
JANUARY 22, 2024
Claud — The Office of Compliance (OC) at FDA’s Center for Drug Evaluation and Research (CDER) had a role in many of the major public health enforcement matters you may have read about last year. OC devoted a lot of resources to its compliance efforts directed at human drug compounding. By John W.M. Clinical Trials.
FDA Law Blog
SEPTEMBER 6, 2023
As predicted in an earlier blogpost , FDA last week released a draft guidance that provides a pathway for generic drug manufacturers to secure a meeting with FDA so that affected companies can get answers to their questions in these circumstances.
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Pharma in Brief
APRIL 25, 2021
As previously reported , the Proposed FDR Amendments were intended to clarify the regulatory requirements under the Abbreviated New Drug Submission (“ ANDS ”) pathway for generic drug products that contain different forms (e.g., Proposed PM(NOC) Amendments Restore Balance by Expanding PM(NOC) Regulation Protections.
Pharmaceutical Technology
JUNE 5, 2023
Earlier this year, Sun Pharmaceutical Industries , one of India’s largest generic drug producers, reported a major cybersecurity breach , impacting its business operations. Right now, it’s compliance by checkbox, in a static way. Pharmaceutical companies that are publicly traded will need to pay attention,” warns Kim.
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.
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. Many of the medicines most badly affected by these shortages are generic drugs to treat common conditions such as diabetes and heart disease. The stakes are high.
Camargo
SEPTEMBER 8, 2021
devices must be regulated as devices, and drugs—if they do not also satisfy the device definition—must be regulated as drugs.”. 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.
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