Articles Tagged with ''Part 11''

INDUSTRY PRESSURE MOUNTS TO ELIMINATE PART 11

Industry groups are stepping up their efforts to revoke 21 CFR Part 11, and the FDA appears to be increasingly willing to succumb to the pressure to eliminate the controversial regulation, according to several sources.

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COALITION PUSHES FOR ELIMINATION OF FDA's PART 11 RULE

An industry group has filed a citizen’s petition urging the FDA to do away with 21 CFR Part 11, saying laws passed since the rule was introduced adequately address issues surrounding the integrity of electronic records and data.

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FDA TO ADDRESS CLINICAL DATA IN NEW GUIDANCE

The FDA is on the verge of releasing a new guidance document that addresses the use of computerized systems in clinical trials, a move that could help the agency establish a consistent, risk-based approach to Part 11 for all segments of the pharmaceutical industry.

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PhRMA RECOMMENDS CHANGES TO PART 11

PhRMA is urging the FDA to withdraw or scale back its Part 11 regulation in favor of other more recently approved legislation addressing electronic records, arguing that the rule is too prescriptive and the cost of compliance too high.

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PhRMA WANTS LEGISLATION USED TO CRAFT eRECORDS POLICY

A major drug industry trade group has suggested the FDA abbreviate or withdraw 21 CFR Part 11 in favor of existing legislative measures to craft policy defining how drugmakers use erecords and esignatures in drug applications, biologics license submissions and other filings with the agency.

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PhRMA TO FDA: SCRAP PART 11, RELY ON LEGISLATION FOR eRECORDS POLICY

The FDA should abbreviate or even withdraw 21 CFR Part 11 and instead rely on legislative measures passed by Congress to craft policy defining how drugmakers use erecords and esignatures in drug applications, biologics license submissions and other filings with the agency, according to a drug industry trade group.

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FDA GATEWAY FOR ELECTRONIC SUBMISSIONS DELAYED

The implementation timeline for the new FDA gateway for electronic submissions has been delayed by “contracting issues,” said Michael Fauntleroy, program manager at the FDA Gateway program and director of the electronic submissions program at the Center for Biologics Evaluation and Research (CBER).

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FDA CANCELS MEETING ON POSSIBLE PART 11 REVISIONS

The FDA’s decision last week to cancel its June 11 public meeting to address possible Part 11 rule revisions created even more confusion in the industry, which has been struggling to get a clear fix on the agency’s direction regarding electronic signatures and electronic recordkeeping.

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FDA CANCELS PART 11 MEETING; PRESENTATIONS TO BECOME COMMENTS

The FDA’s decision to cancel its June 11 public meeting to address possible Part 11 rule revisions has exacerbated an already confused situation in which industry has been unable to get a clear fix on the agency’s direction regarding electronic signatures and electronic recordkeeping.

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