• Regulatory NewsRegulatory News

    FDA Wants Sponsors of Biotech Products to Assess Product's Impact on Environment

    The US Food and Drug Administration's (FDA) Center for Biologics Evaluation and Research (CBER) has released a new draft guidance document meant to clarify when companies need to conduct an Environmental Assessment (EA) for gene therapy and other recombinant products. Background Under 21 CFR 25 of the Code of Federal Regulations , most pharmaceutical and biotechnology companies are required to submit EAs as part of their approval package. The assessments are gene...
  • AdvaMed, Device Companies Claim FDA's 510(k) Pre-Review Guidance Lacks Objectivity

    Several prominent members of the medical device industry, including its largest trade group, have voiced their concerns about a new guidance document released by the US Food and Drug Administration (FDA) that would consolidate and expand the agency's pre-review policies for some medical device applications submitted through the 510(k) pathway. The guidance, Refuse to Accept (RTA) Policy for 510(k)s , is intended to make it easier for FDA to filter out inadequate sub...
  • Supreme Court Rules Company Can Sue Novo Nordisk For Delaying Generic Medication

    • 18 April 2012
    The Supreme Court of the United States ruled 17 April that Caraco Pharmaceuticals can proceed with a lawsuit against Novo Nordisk over Nordisk's purported attempts to prevent Caraco's generic entry into the market, reports various news sources. "At issue was the ability of a brand-name drugmaker to block generic competition by providing the US Food and Drug Administration (FDA) with overly broad descriptions of its patents," writes  Pharmalot . Caraco's lawsuit a...
  • Hamburg: FDA Looking to Increase Port Inspections

    Speaking alongside Senator Jack Kingston and port authority officials in Georgia, US Food and Drug Administration (FDA) Commissioner Margaret Hamburg said the agency is looking to increase the number of inspections taking place at ports of entry into the US. "This year, we expect that nearly 20 million shipments of food, devices, drugs, and cosmetics will arrive at US ports of entry," said Hamburg in remarks 9 April at the Port of Savannah in Georgia. "Just a decade ag...