Don't Change Safety & Effectiveness Standards, FDA Official Urges House Panel03/12/2012 Congress should not change
the standards for determining a therapy’s safety and effectiveness under proposed changes to the agency’s accelerated
approval pathway that are being considered as part of the reauthorization of prescription drug user fees, CDER director Janet
Woodcock told a House hearing 3/8. To expand the accelerated approval program, she said the agency can do more to
provide clarity on the use of this pathway.“We have found that in industry, the academic community and FDA there is
confusion about the use of accelerated approval,” she told the House Energy and Commerce health subcommittee. “We
also plan to issue guidance to clarify use of accelerated approval and explain our evidence standards more clearly.”
[MORE]
FDA Sees Common Problems in Different Drug Shortages3/5/2012 [Report by Kathryn Foxhall*] The same types of problems leading to shortages
with cancer drugs and other medications are issues with antibiotics and antimicrobials, CDER Office of New Drugs deputy director
Sandra Kweder told an advisory meeting at the National Institutes of Health 2/29. There are some shortages
in that arena, but Kweder was asked if such issues in antibiotics and antimicrobials could be a disaster waiting to happen.
Given that most shortages are caused by manufacturing problems, she said, “They are exactly the same issue. They are
sterile injectable products. They are often the same company.” She said, “If you go to the FDA drug shortage page
and you look at the list of drugs in shortage, you can see who makes the product. And what is really remarkable, it’s
often the same names….They come up over and over again.” The problems “are occurring in the same plants,
but maybe on different product lines,” Kweder noted. [READ MORE]
9:47 am
Drug Companies Back Electronic Labeling3/2/2012 Pharmaceutical Research Manufacturers of America (PhRMA), the Biotechnology Industry
Organization (BIO), and several individual drug companies are urging FDA to speed revised drug product labeling to healthcare
providers and patients through electronic means. Comments came in response to FDA’s proposal to establish timeframes
for implementing product safety labeling changes. PhRMA urged FDA to formally establish the National Library of Medicine’s DailyMed Web site as the “primary
authoritative source for product information available to healthcare providers and patients.” [READ MORE]
9:04 am
FDA Blitzes Delinquent Post-Marketing Study Requirements03/01/2012 This week's release of the first Warning Letter to a drug firm (Merck) for not fulfilling a post-marketing study requirement
could be a harbinger of more actions to come. The 2/17 Warning Letter says that the company is more than 20 months late in achieving a 6/15/10 final protocol submission
milestone and more than eight months late in achieving the final report submission milestone in the timetable. It appears
FDA tipped its hand earlier this month about taking post-marketing study commitments seriously when it posted a notice to industry indicating it “intends to vigorously enforce requirements that sponsors conduct postmarket studies
and clinical trials.” [READ MORE]
4:33 pm
FDA Plans Advertising Study on ‘Corrective’ TV AdsCDER advertising and promotion officials want to know how a television direct-to-consumer
corrective ad impacts consumer misperceptions about prescription drug product safety and efficacy. A new study under development
— “Experimental Study: Examination of Corrective Direct-to-Consumer (DTC) Television Advertising” —
aims to screen 19,000 respondents on “message exposure, similarity of original and corrective ads, and length of time
between exposure to original and corrective ad,” according to an agency notice. [READ MORE]
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