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The FDA slammed biologic manufacturer Greer Laboratories in a warning letter for extensive quality problems, including the presence of pests in its manufacturing plant, and making unapproved allergenic extracts. Read More
Two recently issued guidances that aim to clarify standards and electronic formats for regulatory filings have confused some drugmakers who say they need more detail on what types of applications the standards apply to and more time to implement potential format revisions. Read More
A new Citizen Petition contends the FDA should revoke Ranbaxy’s first-to-file market exclusivity status on several lucrative generic drugs due to a clear history of manufacturing problems and intentional false statements made by the Indian generics company. Read More
Manufacturers looking to speed up drug approvals in Europe, and ensure their products will be covered by payers, should initiate early parallel conversations with both the European Medicines Agency and the Health Technology Assessment Bodies (HTABs), the EMA says. Read More
A quartet of GOP senators is criticizing the FDA for relying on draft guidances to implement policy instead of rulemaking, and is clamoring for answers on how long it takes the agency to finalize drafts. Read More
Failing to communicate with a sponsor in a timely manner or collect data from clinical sites may be signs that a CRO isn’t doing its job — and a sign that it’s time for the sponsor to find a new partner, experts say. Read More
The UK’s Medicines and Healthcare products Regulatory Agency is now accepting applications for its Early Access to Medicines Scheme, which allows drugs for life-threatening diseases to be approved on an interim basis and made available to patients sooner. Read More
Australian drug regulators have adopted their European counterparts’ definition of “commercially confidential information” — a move that is raising concerns among some drugmakers who contend that not enough consultation takes place with manufacturers to ascertain what constitutes CCI prior to its disclosure. Read More
The FDA plans to ease requirements for trials of drugs aimed at treating hospital-acquired or ventilator-associated bacterial pneumonia, including allowing sponsors to enroll some subjects in trials before a confirmed diagnosis and easing restrictions on prior antibiotic use — both contentious limitations imposed in current guidance. Read More
The FDA says it will reach out to holders of roughly 375 prescription drug applications filed before June 2001 and ask them to voluntarily adopt the user-friendly labeling format created under the “Physician Labeling Rule.” Read More
The FDA slammed biologic manufacturer Greer Laboratories in a warning letter for extensive quality problems, including the presence of pests in its manufacturing plant, and making unapproved allergenic extracts. Read More