Regulatory Affairs

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An FDA advisory committee may have given its unanimous approval for a biosimilar application this week, but industry and patient groups contend the regulatory pathway still has many potholes, including unanswered questions on naming, labeling, testing requirements and interchangeability of the products. Read More

An FDA advisory committee has thrown its support behind the first publicly acknowledged biosimilar application in the United States. Read More

The FDA extended the expiration date of a previously released final guidance on user fee waivers to August 2017. Read More

The FDA this year aims to answer key questions on which quality metrics it will collect from drugmakers, how to develop biosimilars and how to use social media to promote products. Read More

Drug manufacturers shouldn’t reduce their adverse event reporting practices during an influenza pandemic, the FDA clarified yesterday. Read More

Setting up the new pharmaceutical quality super office is among the roughly dozen top priorities for CDER in 2015. Read More

The FDA’s quality metrics collection program is facing delays as the agency expands it to include biologics manufacturers in addition to drugmakers. Read More

The FDA has pledged to delay enforcement of key elements of its new track and trace regulations for drugmakers, promising that until May 1 it will take no action against companies that do not capture and transmit product information. Read More

Generics makers are pressing the FDA to expand its criteria for granting first-generic status to ANDAs, a move that would put more drugs in line for expedited review. Read More

The FDA’s proposal to survey pharmacists and patients on how changes to the physical appearance of a therapy may affect patient perceptions and drug adherence is raising concerns among both brand and generic drug manufacturers. Read More

The FDA wants to make it easier for generics firms to acquire samples from brandmakers who claim drug safety protocols prevent them from selling the products for bioequivalence testing. Read More

The Office of Generic Drugs is pledging to catch up on a backlog of thousands of ANDAs by October 2017. Read More