Tag Archives: FDA approval

Dealing with Rejection, the Regulatory Kind

trytry-again

The ubiquitous CRL in biotech has made its way into the news headlines again. But is the Complete Response Letter a game-changing hurdle for a biotech, or is it par for the course these days? It turns out that almost half of NDA/BLA filings get rejected by the FDA on the 1st round. However, most companies resubmit their application, and by the 2nd review 75% of drugs gain FDA approval. After heading for a 3rd Read More >

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What Parallel Review Means for Manufacturers

Drug Manufacturing

By Stephen Rothenberg, J.D. and Matt Levy, J.D., Numerof & Associates, Inc. (NAI) Currently, the FDA and CMS consider new medical products in series; after FDA approval or clearance, CMS begins consideration of a National Coverage Determination (NCD), if requested by an interested stakeholder. Any party seeking drug approval (e.g., manufacturers, suppliers, providers, medical professional organizations, and Medicare beneficiaries) may initiate a request for an NCD. In addition, CMS may initiate a request for an Read More >

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Update: Indices, IPOs, and New Drug Approvals

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Here is a look at year to date (YTD) numbers through the end of February for the biotech indices, initial public offerings, and recent FDA Approvals. 1. Indices: The Nasdaq Biotech Index held the January jump through February, settling at + 14% YTD. The concentrated BTK slipped in February, but has outpaced the NBI since January 1st. YTD, both biotech indices have significantly outperformed the broader market. In contrast, the NYSE Pharmaceuticals Index has not Read More >

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Reviewing the drug class of 2011

The drug class of 2011 was larger than the past few graduating classes. We count over 30 new “innovative” drugs found among the list of FDA approvals last year. This is in contrast to the 20-something range of the past few years. On the list are some clear breakthrough treatments and a few glimpses of “the future of biotech”. The specific drugs are listed further below, but first a big picture view: Ten of the approvals were for biologics, Read More >

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The Ethics of Global Clinical Trials

Dr. Russell Medford

By Dr. Russell Medford, Salutria Pharmaceuticals Recent reports have raised concerns about how clinical trials are being performed in other countries, particularly in the developing world. Even prior to these reports, some have asserted that sponsors conduct clinical trials abroad to avoid red tape and avoid overly stringent and time consuming regulatory processes. However, research done by companies with the intent of seeking FDA approval and access to the U.S. market must still meet FDA standards Read More >

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