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To defuse a growing scandal, Valeant Pharmaceuticals has cut ties with a mail-order pharmacy accused of pushing expensive drugs on pharmaceutical buyers. Read More
The FDA handed Baxter Healthcare a six-observation FDA Form 483 for lapses in sterile process controls and failure to review batch discrepancies at its Puerto Rico manufacturing plant. Read More
Despite industry concerns that ICH’s proposed new limits on metals are too strict, the organization released final guidance on elemental impurities in finished drugs that appears little changed from an earlier draft. Read More
In a draft guidance Thursday, the FDA cautions that liposome drug products may respond to chemistry, manufacturing and control (CMC) changes with greater unpredictability than more conventional formulations. Read More
The FDA is once again giving retail and health system pharmacies that act as dispensers four months to ensure that product tracing information required by track-and-trace regulations is captured and maintained. Read More
The FTC is telling the FDA that its proposal to add four-letter suffixes to nonproprietary names for biosimilars and other biological products could be bad for business. Read More