What form is required for an NDA or BLA submission? Group of answer…

QuestionAnswered step-by-stepWhat form is required for an NDA or BLA submission? Group of answer…What form is required for an NDA or BLA submission?  Group of answer choices356h 1572 1571 356i  Flag question: Question 2Question 21 pts What form is submitted for an investigational new drug application (IND)?Group of answer choices1571 1572 356h 356i  Flag question: Question 3Question 31 pts What must be filed with FDA before clinical testing may begin with an investigational drug or biologic?Group of answer choicesIND BLA ELA NDA  Flag question: Question 4Question 41 pts What type of studies are part of the typical pre-clinical phase of biologics development?Group of answer choicesall of the above toxicology pharmacology immunogenicity  Flag question: Question 5Question 51 pts What is the principal difference between a biosimilar and an interchangeable biosimilar?Group of answer choicesa biosimilar is highly similar to the reference product but may not be switched without the intervention of a licensed healthcare practitioner whereas an interchangeable biosimilar may be switched without such intervention. a biosimilar is highly similar to the reference product whereas the interchangeable biosimilar is identical An interchangeable biosimilar is the same as the reference product whereas the biosimilar is not biosimilar is the same as the reference product whereas the interchangeable biosimilar is not  Flag question: Question 6Question 61 pts What year did CDER inherit regulation of therapeutic proteins from CBER?Group of answer choices2003 1902 2007 1997  Flag question: Question 7Question 71 pts Which form is the “Statement of Investigator” that is required for clinical investigations?Group of answer choices1572 1571 356h 356i  Flag question: Question 8Question 81 pts Which section of the U.S. Code provides for the licensure of biosimilars?Group of answer choices351(k) of the PHSA 505(b)(2) of the FD&C Act 351(a) of the PHSA 505(j) of the FD&C Act  Flag question: Question 9Question 91 pts What was the first biosimilar licensed under 351(k) of the Public Health Service Act?Group of answer choicesZarixo Humira Actemra Herceptin  Flag question: Question 10Question 101 pts What is the informal phrase used to describe the exchange of patent and aBLA information under the BPCIA over which many innovator and biosimilar firms are currently litigating?Group of answer choicesThe Patent Dance Hatch Waxman Dispute resolution abbreviated BLA  Flag question: Question 11Question 111 pts How many years of marketing exclusivity accrues to an innovator biologic under the BPCIA?Group of answer choices12 years none 1 year 5 years  Flag question: Question 12Question 121 pts How many years of marketing exclusivity accrues to an interchangeable biosimilar under the BPCIA?Group of answer choices1 year 5 years 12 years 3 years  Flag question: Question 13Question 131 pts What is the duration of a patent term?Group of answer choices20 years 25 years 12 years 5 years  Flag question: Question 14Question 141 pts What is the distinct feature of priority review?Group of answer choices6 month review clock “All Hands on Deck” Approach from FDA, including Senior Leadership rolling review 10 month review clock  Flag question: Question 15Question 151 pts What is the distinguishing feature of “fast track” status?Group of answer choicesrolling review of your BLA “All Hands on Deck” Approach from FDA, including Senior Leadership 6 month review clock 10 month review clock  Flag question: Question 16Question 161 pts Which of the following may be consequences of cGMP violations?Group of answer choicesall of the above EIR with OAI Adulteration charge warning letter  Flag question: Question 17Question 171 pts What is the “animal rule”?Group of answer choicesRule applied for approval or licensure of CBRN countermeasures where field trials in humans are not feasible or would be unethical and where the effect observed in animals is predictive of the anticipated efficacy in humans. Approval based on a surrogate endpoint Authorization to use an investigational product in a public health or national security emergency The rule that codified the “Regenerative Medicine Advanced Therapy Designation.”  Flag question: Question 18Question 181 pts Which section of the U.S. Code provides for full-scale biologics license application (BLA)?Group of answer choices351(a) of the PHSA 505(b)(1) of the FD&C Act 351(k) of the PHSA 505(j) of the FD&C Act  Flag question: Question 19Question 191 pts On what basis does FDA determine jurisdiction for a biologic and device combination product?Group of answer choicesThe primary mode of action the Sponsor makes the election on form 356h the Sponsor makes the election on form 1571 the primary mechanism of action  Flag question: Question 20Question 201 pts True or False: My company could get a priority review voucher for a biologic, previously approved for Duchene’s Muscular Dystrophy, that my company has now received licensure for the treatment of Ebola?Group of answer choicesTrue False  No new data to save. Last checked at 9:55amWhat form is required for an NDA or BLA submission?  Group of answer choices356h 1572 1571 356i  Flag question: Question 2Question 21 pts What form is submitted for an investigational new drug application (IND)?Group of answer choices1571 1572 356h 356i  Flag question: Question 3Question 31 pts What must be filed with FDA before clinical testing may begin with an investigational drug or biologic?Group of answer choicesIND BLA ELA NDA  Flag question: Question 4Question 41 pts What type of studies are part of the typical pre-clinical phase of biologics development?Group of answer choicesall of the above toxicology pharmacology immunogenicity  Flag question: Question 5Question 51 pts What is the principal difference between a biosimilar and an interchangeable biosimilar?Group of answer choicesa biosimilar is highly similar to the reference product but may not be switched without the intervention of a licensed healthcare practitioner whereas an interchangeable biosimilar may be switched without such intervention. a biosimilar is highly similar to the reference product whereas the interchangeable biosimilar is identical An interchangeable biosimilar is the same as the reference product whereas the biosimilar is not biosimilar is the same as the reference product whereas the interchangeable biosimilar is not  Flag question: Question 6Question 61 pts What year did CDER inherit regulation of therapeutic proteins from CBER?Group of answer choices2003 1902 2007 1997  Flag question: Question 7Question 71 pts Which form is the “Statement of Investigator” that is required for clinical investigations?Group of answer choices1572 1571 356h 356i  Flag question: Question 8Question 81 pts Which section of the U.S. Code provides for the licensure of biosimilars?Group of answer choices351(k) of the PHSA 505(b)(2) of the FD&C Act 351(a) of the PHSA 505(j) of the FD&C Act  Flag question: Question 9Question 91 pts What was the first biosimilar licensed under 351(k) of the Public Health Service Act?Group of answer choicesZarixo Humira Actemra Herceptin  Flag question: Question 10Question 101 pts What is the informal phrase used to describe the exchange of patent and aBLA information under the BPCIA over which many innovator and biosimilar firms are currently litigating?Group of answer choicesThe Patent Dance Hatch Waxman Dispute resolution abbreviated BLA  Flag question: Question 11Question 111 pts How many years of marketing exclusivity accrues to an innovator biologic under the BPCIA?Group of answer choices12 years none 1 year 5 years  Flag question: Question 12Question 121 pts How many years of marketing exclusivity accrues to an interchangeable biosimilar under the BPCIA?Group of answer choices1 year 5 years 12 years 3 years  Flag question: Question 13Question 131 pts What is the duration of a patent term?Group of answer choices20 years 25 years 12 years 5 years  Flag question: Question 14Question 141 pts What is the distinct feature of priority review?Group of answer choices6 month review clock “All Hands on Deck” Approach from FDA, including Senior Leadership rolling review 10 month review clock  Flag question: Question 15Question 151 pts What is the distinguishing feature of “fast track” status?Group of answer choicesrolling review of your BLA “All Hands on Deck” Approach from FDA, including Senior Leadership 6 month review clock 10 month review clock  Flag question: Question 16Question 161 pts Which of the following may be consequences of cGMP violations?Group of answer choicesall of the above EIR with OAI Adulteration charge warning letter  Flag question: Question 17Question 171 pts What is the “animal rule”?Group of answer choicesRule applied for approval or licensure of CBRN countermeasures where field trials in humans are not feasible or would be unethical and where the effect observed in animals is predictive of the anticipated efficacy in humans. Approval based on a surrogate endpoint Authorization to use an investigational product in a public health or national security emergency The rule that codified the “Regenerative Medicine Advanced Therapy Designation.”  Flag question: Question 18Question 181 pts Which section of the U.S. Code provides for full-scale biologics license application (BLA)?Group of answer choices351(a) of the PHSA 505(b)(1) of the FD&C Act 351(k) of the PHSA 505(j) of the FD&C Act  Flag question: Question 19 On what basis does FDA determine jurisdiction for a biologic and device combination product?Group of answer choicesThe primary mode of action the Sponsor makes the election on form 356h the Sponsor makes the election on form 1571 the primary mechanism of action  Flag question: Question 20 True or False: My company could get a priority review voucher for a biologic, previously approved for Duchene’s Muscular Dystrophy, that my company has now received licensure for the treatment of Ebola?Group of answer choicesTrue False   Social SciencePolitical ScienceRGA 6101Share 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