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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In a draft guidance Thursday, the FDA cautions that liposome drug products may respond to chemistry, manufacturing and control (CMC) changes with greater unpredictability than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
Warner Chilcott has agreed to pay $125 million to settle charges that it paid kickbacks to physicians to induce them to prescribe seven drugs, and the company’s former president was charged with conspiring to pay the kickbacks, the Department of Justice announced Thursday. Read More