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The FDA warned an active pharmaceutical ingredient manufacturer for not paying its facility user fees. However, the company says it hasn’t made APIs since 2008. Read More
Generics makers with first-to-file ANDA status say they are frustrated by the FDA’s slow approval times, claiming their 180-day market exclusivity period is jeopardized by agency inaction. Read More
Boston-based Epirus Biopharmaceuticals has received final approval in India for its biosimilar of the autoimmune therapy Remicade, making it the first biosimilar of the product in that country. Read More
The FDA for the first time has published a reference list for biologics, known as the Purple Book, that will list all brand products and any biosimilars with which they are interchangeable. Read More
The FDA’s database of inactive drug ingredients needs a complete overhaul to better facilitate ANDA filings, say generics makers who laid out a variety of other shortfalls they see in the agency’s generic drug approval process. Read More
The FDA needs to clarify whether its 10-day ANDA correspondence clock starts ticking once a manufacturer receives the agency’s communication or at the moment the agency mails it, say generics firms, which also urge the FDA to start sending all communications by fax or email. Read More
European regulators have approved Eli Lilly and Boehringer Ingelheim’s insulin glargine drug Abasria, a biosimilar version of Sanofi’s blockbuster product Lantus. Read More
The FDA is moving to ease industry fears that ANDAs filed after September of this year will receive priority over earlier applications simply because they were filed before the law required the agency to assign review deadlines to new applications. Read More
The European Ombudsman has accused EU regulators of blocking access to drug safety reports and other public documents in a new case that observers tell DID is part of the watchdog’s ongoing effort to bring greater transparency to the pharmaceutical industry. Read More
India’s drug regulatory authority has abruptly withdrawn a guideline for setting prices on many branded-generic drugs, a move that could help manufacturers press their case in a lawsuit against the government’s drug-pricing policies. Read More
Two New York congressmen have become the latest on Capitol Hill to question a proposed FDA rule that would give generics firms the same authority to change drug labels as brandmakers, a rule that GPhA has threatened to challenge in court if necessary. Read More