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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
Manufacturers developing biosimilars in Europe want regulators to go back to comparing their therapies with the reference product based on the actual amount of active ingredient in a dose rather than a proposed standard that compares dosages and routes of administration. Read More
GPhA is pushing for more states to pass automatic biosimilar substitution laws next year using draft language that eliminates requirements to notify prescribers of a swap with the brand. Read More
Addressing the ANDA backlog, setting up the pharmaceutical quality office, and issuing final guidance on abuse-deterrent opioids are among the roughly dozen top priorities for CDER in 2015. Read More
Biosimilars promise to remain center stage in 2015 after the industry spent much of 2014 squabbling over everything from naming to substitution and the exact requirements of the pathway. Read More
In a preview of how the FDA’s Office of Pharmaceutical Quality will speed approval of generic drugs, the office is rolling out a framework for ANDA filers to respond to minor agency queries involving chemistry, manufacturing and control issues early in the review cycle. Read More