1. Time after filing a protocol under and IND (drugs) and FDA approval to proceed with enrollment.
2. Also, the time period between when a a company submits an IND and when it can initiate a protocol
3. Timeline may be extended if FDA does not agree with the proposed protocol.

120-day safety report

Amendment to an NDA containing a safety update due 120 days after the NDA is filed.

Application submitted for a drug for which...

at least 1 of the investigations relied on by applicant for approval of the 'application were

• not conducted for or by the applicant and
• for which the applicant has NOT obtained a right of reference or use from the person by or for whom the investigations were conducted"

Traditional 510(k) (FDA 90 days): demonstrate that medical device to be mkted is as safe and effective or "SE" to a legally marketed device.

Special 510(k):  (FDA 30 days) For device modifications that

• do not affect the intended use 
• do not alter the fundamental scientific technology

Abbreviated 510(k): supported by conformance with guidance document(s), special controls, or standards

containing filthy, putrid, or decomposed substance

prepared under unsanitary conditions

not made according to GMPs

containing unsafe color additive

does not meet requirements of official compendium

new pathway to expedite development of therapies showing substantial promise in early clinical trials.

drug company may seek breakthrough therapy designation if drug is developed for a serious and life threatening disease AND preliminary evidence shows that the drug may offer substantial improvement over existing therapies on one or more clinically significant endpoints

Complete response letter

communicates FDA's decision to a drug company its NDA or ANDA to market a new generic drug will NOT be approved in its present form.

includes most submissions under an active IND

• new protocols
• final study reports
• safety reports
• CMC information

firm-initiated removal or correction of a device, drug, or biologic product involving a minor violation of the FD&C act

not subject to legal action by FDA

OR

which involves no violation (e.g. stock rotation practices, routine equipment adjustments and repairs, etc.)

analogous to drug master file.

- submission to FDA that may be used to provide confidential or detailed information about a medical device or a component used int he mfr of a medical device to FDA in support of another party's oblication

incorrectly labeled product

false or misleading or

fails to include info required by law

failure to obtain a 510(k) for a device

drugs for disease or condition affecting <200k ppl in US 

OR

in more than 200k and for which there is no reasonable expectation the drug development and mfring costs will be recovered from US sales

few subjects

healthy volunteers

PK, ADME, dose escalation studies

Phase II clinical trial

well-controlled

100-300 ppl, having condition of interest

PK, dose ranging, safety, efficacy

large 100s-1000s

well-controlled

establish safety and additional efficacy

- Required for class III devices

• Traditional PMA: complete PMA submitted to FDA at once
• Modular PMA: complete contents of PMA are broken down into modules and submitted to FDA as soon as applicant has completed module
• Streamlined: for a device in which the technology and use are well known to FDA
• Product development process (PDP): clinical evaluation and other info necessary for marketing approval are merged into one regulatory mxn.  when device technology is well established in industry

Class 1: violative device would cause serious adverse health consequences

Class II: may cause temporary or medically reversible consequences, or consequences are remote

Class III: not likely to cause adverse health consequences

serious enforcement letter issued by FDA notifying a regulated entity of violative activity

requires immediate action within 15 days