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The FDA has proposed rule changes critical to deciding which agency product center will take the lead on regulatory oversight of a particular combination product.
Two days after HHS Secretary Tommy Thompson said he believed Congress would pass legislation this session authorizing the importation of drugs from other countries, the head of a national retail pharmacy chain became the first industry leader to publicly endorse the concept.
Drugmakers that implement detailed, proactive risk management action plans (RiskMAPs) can minimize the impact of known risks associated with approved drugs without encumbering product availability, according to a draft guidance released yesterday by the agency.
Once a drug is on the market, collecting safety data and assessing risks based on observational data are critical for evaluating and characterizing a product's risk profile and for making informed decisions to minimize those risks, the FDA said in a draft guidance released yesterday.
When assessing the risks of an investigational drug, drugmakers may need to build larger safety databases, especially in connection with proposed treatments for which a safe and effective alternative is already in use, according to an FDA draft guidance on risk management released yesterday.
Following up on risk management concept papers issued last spring, the FDA yesterday released three draft guidances to help drug manufacturers achieve more benefits from drug and biologic products while minimizing their risks.
For the FDA to approve a generic biologic, the agency would have to rely on an innovator firm’s trade secret data covering the product’s manufacturing process — something that is prohibited by law, argues biotech firm Genentech.
While the effects of last year’s drug patent reforms are still sinking in, one change has become clear: The agency has not received a single polymorph patent for filing in the FDA’s Orange Book since the new rules kicked in last August, according to agency officials.
The FDA has asked Pfizer, in an untitled letter, to immediately stop disseminating some promotional materials for Zyrtec-D, because the company misbranded the drug by failing to properly disclose some contraindications and warnings contained in its approved labeling.