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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.
Industry group says that even though the FDA’s promulgation of three draft guidance documents on risk assessment and minimization will go a long way in establishing a framework for industry and the agency, some components of the guidances may actually delay the availability of new and beneficial drugs.
Several senators are calling for the creation of a national registry of drug trials that would considerably expand the scope of the existing database at clinicaltrials.gov. The calls follow delays by pharmaceutical manufacturers in reporting the results of their clinical drug trials to a federal government website.
While the FDA’s promulgation of three draft guidance documents on risk assessment and minimization will go a long way to establishing a framework for industry and the agency, some components of the guidances may actually delay the availability of new and beneficial drugs, according to PhRMA.
Delays by pharmaceutical manufacturers in reporting the results of clinical drug trials to a federal government website have led several senators to call for the creation of a national registry of drug trials that would considerably expand the scope of the existing database at clinicaltrials.gov.
PhRMA has adopted new voluntary principles to encourage drugmakers to release comprehensive data about clinical trials, amid growing controversy about the suppression of negative trial results.
The pharmaceutical industry is not complying with a law that requires drugmakers to report data on industry-sponsored cancer clinical trials to a federal website, according to a powerful House lawmaker.
The Senate last week approved a bill that would end European trade sanctions against U.S. businesses and would extend by 18 months a research and development (R&D) corporate tax credit set to expire June 30, according to an official at a manufacturing trade group whose members include PhRMA and the Biotechnology Industry Organization.
The FDA should implement an administrative penalty to discourage generic drug firms from missing deadlines for submitting notifications that start the 45-day clock for drugmakers to file patent-infringement lawsuits, PhRMA said in comments suggesting changes in FDA drug patent rules.
It appears unlikely that the current research and development (R&D) tax credit for corporations will be extended by Congress before it expires June 30, despite intense lobbying by business interests, including pharmaceutical company representatives, according to knowledgeable sources.