FDA

Sun Pharma is facing renewed scrutiny after a scathing US Food and Drug Administration inspection at its Halol facility in Gujarat painted a grim picture of a facility operating in disregard of basic pharmaceutical safety standards.

Senate appropriators also put FDA on notice regarding recent meetings and compliance with the Federal Advisory Committees Act, signal positive news on rare pediatric diseases, and offer hints of other agency areas they have close eyes on.

The company had planned to keep its DMD gene therapy available for ambulatory patients, but now says pausing shipments may enable a better working relationship with the US FDA while safety labeling is updated.

Recent FDA warning letter claims Boston firm specializing in wearable technology marketed a blood pressure device without agency approval, but the company rejects the assertion and says the agency is out of step with federal regulations.

Texas Democrat Lizzie Fletcher didn’t pose questions for witnesses at House Health Subcommittee hearing but used her floor time to question whether Congress will keep federal agencies afloat. “I have real concerns that even if we reauthorize these programs, we won't have the funding or the staff to

Sarepta knew about the death in a Phase I trial of SRP-9004 for LGMD when it recently revealed a restructuring plan, but did not disclose the event. The now-discontinued gene therapy candidate uses the same AAV vector as Elevidys, which has been linked to two DMD patient deaths.

Bio-Thera is one step closer to launching a biosimilar to Johnson & Johnson’s Simponi in the US, following FDA acceptance of its BAT2506 proposed golimumab candidate.

FDA’s fourth approval in past two months for color derived from natural sources to use in foods is Gardenia Blue Interest Group’s color additive petition for gardenia blue. Lycored launches StellarYellow and C Clear as alternatives for synthetic dyes yellow Nos. 5 and 6 and OrangeOvation C Clear for

Subcommittee members aren’t on same page about whether FDA staff cuts ordered by the Trump administration will prevent the agency from fulfilling its responsibilities for the OTC drug sector.

In this week's Digital Health Roundup, Medtech Insight's team discusses progress on autonomous surgery, Medtronic's new partnership with IRCAD, FDA cybersecurity news, and C-suite interviews with OpenWater, Flow Neuroscience and EnsoData.

Teva seeks a dedicated development program and first-cycle approval metrics for complex generics. Role of artificial intelligence in the generic drug review process is a talking point for both agency and industry at reauthorization kickoff meeting.

Recent warning letters to seven companies marketing products with kratom extract known as 7-OH are FDA’s first in three years referencing unlawful products containing kratom and the first of all its kratom-related warnings to reference extracts from the botanical.