Podcast
Questions and Answers
Why was the Pure Food and Drug Act of 1906 considered ineffective?
Why was the Pure Food and Drug Act of 1906 considered ineffective?
- It was immediately repealed due to public outcry.
- It focused solely on preventing the import of foreign drugs.
- It only applied to food products, not drugs.
- It lacked enforcement mechanisms to hold violators accountable. (correct)
What critical requirement for drugs was introduced by the Food, Drug, and Cosmetic Act that didn't exist before?
What critical requirement for drugs was introduced by the Food, Drug, and Cosmetic Act that didn't exist before?
- Drugs had to be tested on animals before human trials.
- Drugs had to be manufactured domestically.
- Drugs had to be proven effective before marketing.
- Drugs had to be proven safe before marketing. (correct)
What event significantly influenced the passage of the Food, Drug, and Cosmetic Act?
What event significantly influenced the passage of the Food, Drug, and Cosmetic Act?
- A mass poisoning incident involving a drug that used antifreeze as a solvent. (correct)
- A widespread outbreak of foodborne illness caused by contaminated produce.
- The discovery of a new antibiotic with severe side effects.
- The publication of a report exposing unsanitary conditions in meatpacking plants.
What was the primary focus of the Kefauver-Harris Amendments of 1962?
What was the primary focus of the Kefauver-Harris Amendments of 1962?
What key aspect does the Modernization Act of 1997 address concerning pharmaceutical companies?
What key aspect does the Modernization Act of 1997 address concerning pharmaceutical companies?
During the NDA process, what is the FDA's initial step upon receiving a submission?
During the NDA process, what is the FDA's initial step upon receiving a submission?
What type of information about a new drug application becomes publicly available during the FDA review process?
What type of information about a new drug application becomes publicly available during the FDA review process?
What is a Subpart H approval, and under what circumstances might it be granted?
What is a Subpart H approval, and under what circumstances might it be granted?
How does the patient population in Phase 3 clinical trials affect the scope of a drug's approval?
How does the patient population in Phase 3 clinical trials affect the scope of a drug's approval?
What type of data is submitted to the FDA as part of a New Drug Application (NDA)?
What type of data is submitted to the FDA as part of a New Drug Application (NDA)?
Why is patent information included in a New Drug Application (NDA)?
Why is patent information included in a New Drug Application (NDA)?
Based on Katie Lyons' experiences, what motivated her to transition into the regulatory field?
Based on Katie Lyons' experiences, what motivated her to transition into the regulatory field?
What was Kelly Hogan's initial area of focus within the pharmaceutical industry?
What was Kelly Hogan's initial area of focus within the pharmaceutical industry?
What is the significance of the proposed drug labeling that is submitted as part of the NDA?
What is the significance of the proposed drug labeling that is submitted as part of the NDA?
How did the Sulfanilamide crisis in Europe impact drug regulation in the United States?
How did the Sulfanilamide crisis in Europe impact drug regulation in the United States?
Prior to the Food Drug and Cosmetic Act, what was a major deficiency in drug regulation?
Prior to the Food Drug and Cosmetic Act, what was a major deficiency in drug regulation?
What is the FDA's role regarding promotional materials for drugs that receive Subpart H approval?
What is the FDA's role regarding promotional materials for drugs that receive Subpart H approval?
What is typically the timeframe for the FDA to acknowledge receipt of a New Drug Application (NDA)?
What is typically the timeframe for the FDA to acknowledge receipt of a New Drug Application (NDA)?
What does it mean when the FDA communicates that an NDA has been 'filed'?
What does it mean when the FDA communicates that an NDA has been 'filed'?
Why did the speaker transition from a medical role to regulatory affairs?
Why did the speaker transition from a medical role to regulatory affairs?
According to the speaker, what is a significant challenge associated with lengthy drug labels?
According to the speaker, what is a significant challenge associated with lengthy drug labels?
Which of the following is NOT a typical component of a New Drug Application (NDA)?
Which of the following is NOT a typical component of a New Drug Application (NDA)?
In the context of drug approvals, what does the use of a 'surrogate marker' imply?
In the context of drug approvals, what does the use of a 'surrogate marker' imply?
What prompted changes in promotional regulations following the 1962 Kefauver-Harris Amendments?
What prompted changes in promotional regulations following the 1962 Kefauver-Harris Amendments?
Which step comes first?
Which step comes first?
Flashcards
Food Drug Cosmetic Act
Food Drug Cosmetic Act
Requires drugs to be safe before marketing.
Modernization Act of 1997
Modernization Act of 1997
Deals with pharmaceutical companies communicating about products before launch
NDA Submission Info
NDA Submission Info
A notification that a submission has occurred will be made public, but not anything after the fact until it actually occurs.
NDA contents
NDA contents
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Kefauver-Harris Amendments of 1962
Kefauver-Harris Amendments of 1962
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FDA's NDA Review Stages
FDA's NDA Review Stages
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Pure Food and Drug Act (1906)
Pure Food and Drug Act (1906)
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Drug Approval Parameters
Drug Approval Parameters
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Study Notes
Introductions
- Katie Lyons has been in the pharmaceutical industry since 2000, with a background as a clinical pharmacist and experience in field work, in-house medical strategy, global publication plans, and regulatory roles.
- Katie's regulatory experience focuses on regulations around commercialization, working closely with commercial colleagues, and she was always asking questions.
- Kelly Hogan has a pharmacy background and has been in the industry since around 1999/2000, with a career focused on phase three clinical trial work.
Drug Approval Requirements
- Approval is based on the Phase 3 population studied
- Narrow patient population leads to narrow indication
- Evaluating a surrogate marker instead of a clinical marker may lead to a subpart H approval
- Subpart H approval requires FDA to approve and review all materials before promotion
- Adequate manufacturing and appropriate labels are necessary for approval
- Study design impacts approval
FDA Authority
- 1906 Pure Food and Drug Act
- Designed to prevent snake oils from going into interstate commerce
- Lacked enforcement mechanisms
- 1937: 107 children died due to the use of antifreeze as a solvent in medication
- Food Drug Cosmetic Act
- First time a drug had to be proven safe before marketing
- Established the FDA
- 1962 Kefauver-Harris Amendments
- Prompted by Sulfanilamide causing birth defects in Europe
- Drugs must be proven both effective and safe
- Led to regulations for promotion
- 1997 Modernization Act
- Addressed communication about products before launch
New Drug Application (NDA)
- Meeting held with the FDA to present the NDA package a month in advance
- Includes clinical data, preclinical data, and statistics
- FDA has three stages
- Receipt: Acknowledges receipt of the submission
- Filing: Confirms all main components are present within 60 days
- Refusal to File: Occurs if key components are missing
- Contents
- Preclinical data
- Pharmacokinetics
- Clinical information
- Patents
- Proposed drug labeling
- Press releases regarding submissions are made public
- Notification that a submission has occurred is public knowledge
- Information on the review process remains confidential until it's completed
- Proposed label submitted to the FDA can be extensive, such as 51 pages long
- This is a primary resource for physicians, but may be too long to analyze effectively
- Physician drug labeling changes occurred about ten years ago
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