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Investigational new drugs, including biologic drugs, will face new safety reporting requirements designed to increase timeliness as well as decrease unnecessary reporting of events not likely to be causal.
The changes bring the Food and Drug Administration's reporting policies in line with international agencies, including the World Health Organization (WHO).
The changes focus on the reporting of adverse events clearly linked to the drug that occur during animal or human testing of the agent.
Adherence to the former rule often resulted in reporting of events not likely to be associated with the drug, slowing recognition of truly causal effects, according to the draft guidance.
Under the new rule, applicants may submit only “suspected adverse reactions,” defined as events for which there is “evidence to suggest a causal relationship between the drug and the adverse event,” according to a FDA draft guidance for investigators.
Other reportable findings include data concerning bioequivalence of generic biologic drugs, compared with their name-brand counterparts — for example, differing rates of absorption into the bloodstream.
To see the full text of the final rule, visit http://tinyurl.com/36fld9u
Investigational new drugs, including biologic drugs, will face new safety reporting requirements designed to increase timeliness as well as decrease unnecessary reporting of events not likely to be causal.
The changes bring the Food and Drug Administration's reporting policies in line with international agencies, including the World Health Organization (WHO).
The changes focus on the reporting of adverse events clearly linked to the drug that occur during animal or human testing of the agent.
Adherence to the former rule often resulted in reporting of events not likely to be associated with the drug, slowing recognition of truly causal effects, according to the draft guidance.
Under the new rule, applicants may submit only “suspected adverse reactions,” defined as events for which there is “evidence to suggest a causal relationship between the drug and the adverse event,” according to a FDA draft guidance for investigators.
Other reportable findings include data concerning bioequivalence of generic biologic drugs, compared with their name-brand counterparts — for example, differing rates of absorption into the bloodstream.
To see the full text of the final rule, visit http://tinyurl.com/36fld9u
Investigational new drugs, including biologic drugs, will face new safety reporting requirements designed to increase timeliness as well as decrease unnecessary reporting of events not likely to be causal.
The changes bring the Food and Drug Administration's reporting policies in line with international agencies, including the World Health Organization (WHO).
The changes focus on the reporting of adverse events clearly linked to the drug that occur during animal or human testing of the agent.
Adherence to the former rule often resulted in reporting of events not likely to be associated with the drug, slowing recognition of truly causal effects, according to the draft guidance.
Under the new rule, applicants may submit only “suspected adverse reactions,” defined as events for which there is “evidence to suggest a causal relationship between the drug and the adverse event,” according to a FDA draft guidance for investigators.
Other reportable findings include data concerning bioequivalence of generic biologic drugs, compared with their name-brand counterparts — for example, differing rates of absorption into the bloodstream.
To see the full text of the final rule, visit http://tinyurl.com/36fld9u