In response to last week’s blog about FDA’s announcement that, in future reviews of NDAs, it will ditch approvable and nonapprovable letters for “neutral” complete-review letters, Russ Somma sent an interesting and informative take on the likely effect of the new system on the industry. Somma is president of SommaTech, a pharmaceutical development technology consulting company in Somerset, NJ. He has an impressive track record of over 21 successful NDAs and more than 50 product and product assessments in only three years. He writes:

The FDA’s “complete response” letter to New Drug Applications (NDAs) will be a challenge for both sponsor companies and market watchers. While the letter is already business as usual in the biologic and vaccine areas, the decision by the Center for Drug Evaluation and Review (CDER) to use it starting August 11 for the “small molecule” players—supposedly for the sake of consistency—will create more confusion, or at least debate, for the industry. (more…)