BCPS Regulatory(LATEST UPDATE
2024)CORRECT 100%
New drug approval pathway - ANSWER NDA (New Drug Application)
Generic drug approval pathway - ANSWER ANDA (Abbreviated New Drug
Application)
FDA's duties - ANSWER 1. Review and approval of NDA and ANDA
2. Determine if REMS is necessary
3. Post-marketing surveillance
4. Mfr oversight and Quality
5. Dietary Supplements
Sentinel Event = ? - ANSWER An UNEXPECTED event that leads to significant harm,
injury, or death.
Example: death due to medication use, leg amputation, loss of organ function
(liver, kidney), attempted suicide, etc.
Sentinel Event is not ______ - ANSWER Not common, well known adverse effects
(eg constipation d/t opioid, edema d/t CCB, etc)
What is MedWatch? - ANSWER Program under the FDA for health professionals
AND consumers to report sentinel events or drug adverse effects. Can inform drug
recalls, labeling updates, and clinical safety updates.
, What other incidents can be reported through MedWatch - ANSWER quality
problems, therapeutic inequivalence of a generic drug, product use errors with Rx
drugs, biologics, MEDICAL DEVICES, or dietary supplements.
Is MedWatch mandatory or voluntary? - ANSWER 100% voluntary.
What is MedWatch Form 3500 for? - ANSWER Health professionals
What is MedWatch Form 3500B for? - ANSWER Consumers and non-healthcare
personnel
What does the NQF do? - ANSWER Endorse healthcare standards and quality
measures
How does NQF differ from TJC? - ANSWER TJC has ORYX. NQF helps recommend
which quality measures should be used in payment models and public reporting
programs. NQF also provides reports and tools to help providers stay on top of
quality improvement and quality standards.
Examples of NQF quality measures? - ANSWER follow-up care from inpatient
admission for acute MI, DM care including BP, eye exams, A1c goals, cholesterol
mgmt
What are the consequences of not staying on top of quality standards? - ANSWER
Loss of revenue (fee for service is changing to a more quality based payment
system)
,What is the IND? - ANSWER Investigational New Drug Application, before starting
Phase 1 studies
What are the focuses on Phase 1 trials? - ANSWER PK, PD, safety, ADR based on
different dosages. First time an investigational drug is given to humans. Healthy,
younger subjects. Less than 100 subjects. Not necessarily subjects w/ the disease
state intended to treat. Timeline: several months.
What are the focuses of Phase 2 trials? - ANSWER Given to pt with the disease
intended to treat, look for efficacy. Often randomized and blinded. Look for
tolerability and SE. Several hundreds of subjects. Can be for a couple of years.
What do phase 3 trials focus on? - ANSWER Efficacy and safety. Several thousands
of patients. Determine the dosing. Multiple sites. Randomized and blinded. After
Phase 3, can submit NDA.
What do Phase 4 studies do? - ANSWER post-marketing surveillance. Look for long
term ADRs that aren't reported out of previous phases. May lead to labeling
updates, REMs if needed. May collect data for other indications or demonstrate
cost-effectiveness.
How long is a drug patent for? - ANSWER typically 20 years from the time of
application, or about 7 years after drug approval.
What is the ANDA? - ANSWER Abbreviated New Drug Application (generic drugs)
What do ANDA sponsors have to do? - ANSWER prove bioequivalence of generic
version. No need to prove efficacy through the 3 phases of clinical trials that NDA
requires.
, What's the benefit of ANDA? - ANSWER Lower cost drugs (generics)
Who oversees the NDA and ANDA? - ANSWER CDER (which is under the FDA)
Can a drug be switched from Rx to OTC? - ANSWER Yes, CDER will oversee this
process. CDER will want to make sure that the drug is safe as OTC.
What is the CBER - ANSWER Center of Biologics Evaluation and Research (also
under FDA)
What is the BLA? - ANSWER Biologics License Application. The NDA of biologics.
Manufacturers can begin interstate commerce of biologics with BLA.
What does the Purple Book do? - ANSWER show interchangeability of biosimilars
to comparator reference biologics.
What does the Orange Book do? - ANSWER show therapeutic equivalence of
generic drugs to brand drugs
What law allowed the Orange Book to be published? - ANSWER Hatch-Waxman
Amendments from 1984.
What is the DMEPA? - ANSWER Division of Medication Error Prevention and
Analysis, under the CDER (which is under the FDA)
2024)CORRECT 100%
New drug approval pathway - ANSWER NDA (New Drug Application)
Generic drug approval pathway - ANSWER ANDA (Abbreviated New Drug
Application)
FDA's duties - ANSWER 1. Review and approval of NDA and ANDA
2. Determine if REMS is necessary
3. Post-marketing surveillance
4. Mfr oversight and Quality
5. Dietary Supplements
Sentinel Event = ? - ANSWER An UNEXPECTED event that leads to significant harm,
injury, or death.
Example: death due to medication use, leg amputation, loss of organ function
(liver, kidney), attempted suicide, etc.
Sentinel Event is not ______ - ANSWER Not common, well known adverse effects
(eg constipation d/t opioid, edema d/t CCB, etc)
What is MedWatch? - ANSWER Program under the FDA for health professionals
AND consumers to report sentinel events or drug adverse effects. Can inform drug
recalls, labeling updates, and clinical safety updates.
, What other incidents can be reported through MedWatch - ANSWER quality
problems, therapeutic inequivalence of a generic drug, product use errors with Rx
drugs, biologics, MEDICAL DEVICES, or dietary supplements.
Is MedWatch mandatory or voluntary? - ANSWER 100% voluntary.
What is MedWatch Form 3500 for? - ANSWER Health professionals
What is MedWatch Form 3500B for? - ANSWER Consumers and non-healthcare
personnel
What does the NQF do? - ANSWER Endorse healthcare standards and quality
measures
How does NQF differ from TJC? - ANSWER TJC has ORYX. NQF helps recommend
which quality measures should be used in payment models and public reporting
programs. NQF also provides reports and tools to help providers stay on top of
quality improvement and quality standards.
Examples of NQF quality measures? - ANSWER follow-up care from inpatient
admission for acute MI, DM care including BP, eye exams, A1c goals, cholesterol
mgmt
What are the consequences of not staying on top of quality standards? - ANSWER
Loss of revenue (fee for service is changing to a more quality based payment
system)
,What is the IND? - ANSWER Investigational New Drug Application, before starting
Phase 1 studies
What are the focuses on Phase 1 trials? - ANSWER PK, PD, safety, ADR based on
different dosages. First time an investigational drug is given to humans. Healthy,
younger subjects. Less than 100 subjects. Not necessarily subjects w/ the disease
state intended to treat. Timeline: several months.
What are the focuses of Phase 2 trials? - ANSWER Given to pt with the disease
intended to treat, look for efficacy. Often randomized and blinded. Look for
tolerability and SE. Several hundreds of subjects. Can be for a couple of years.
What do phase 3 trials focus on? - ANSWER Efficacy and safety. Several thousands
of patients. Determine the dosing. Multiple sites. Randomized and blinded. After
Phase 3, can submit NDA.
What do Phase 4 studies do? - ANSWER post-marketing surveillance. Look for long
term ADRs that aren't reported out of previous phases. May lead to labeling
updates, REMs if needed. May collect data for other indications or demonstrate
cost-effectiveness.
How long is a drug patent for? - ANSWER typically 20 years from the time of
application, or about 7 years after drug approval.
What is the ANDA? - ANSWER Abbreviated New Drug Application (generic drugs)
What do ANDA sponsors have to do? - ANSWER prove bioequivalence of generic
version. No need to prove efficacy through the 3 phases of clinical trials that NDA
requires.
, What's the benefit of ANDA? - ANSWER Lower cost drugs (generics)
Who oversees the NDA and ANDA? - ANSWER CDER (which is under the FDA)
Can a drug be switched from Rx to OTC? - ANSWER Yes, CDER will oversee this
process. CDER will want to make sure that the drug is safe as OTC.
What is the CBER - ANSWER Center of Biologics Evaluation and Research (also
under FDA)
What is the BLA? - ANSWER Biologics License Application. The NDA of biologics.
Manufacturers can begin interstate commerce of biologics with BLA.
What does the Purple Book do? - ANSWER show interchangeability of biosimilars
to comparator reference biologics.
What does the Orange Book do? - ANSWER show therapeutic equivalence of
generic drugs to brand drugs
What law allowed the Orange Book to be published? - ANSWER Hatch-Waxman
Amendments from 1984.
What is the DMEPA? - ANSWER Division of Medication Error Prevention and
Analysis, under the CDER (which is under the FDA)
