A new report from the Institute of Medicine (IOM) concludes the US Food and Drug Administration (FDA) needs to make investments into advancing the regulatory capacity of developing low- and middle-income nations in order to secure the pharmaceutical supply chain and safeguard the American public. The report, Ensuring Safe Foods and Medical Products Through Stronger Regulatory Systems Abroad , recommends 13 steps FDA and other regulatory bodies can take in the next five ...

An active pharmaceutical ingredient (API) inspection program involving many of the world's premiere global regulatory bodies announced recently its intent to standardize the inspection schemes of the member nations and advance "administrative simplification." The as-yet-unnamed program, which includes the US Food and Drug Administration (FDA), the European Medicines Agency (EMA), Australia's Therapeutic Goods Administration (TGA), the World Health Organization (WHO), the...

Health Canada released an updated document Wednesday (28 March) detailing the results of all clinical trial inspections conducted by the agency between 1 April 2004 and 31 March 2011, showing 8% of all clinical trials inspected by Health Canada to be noncompliant with Canadian regulations. The update is the third since the launch of the program, and is intended to "increase awareness of Canadian regulatory requirements within the clinical research community, while mainta...

Two petitions from pharmaceutical manufacturer AstraZeneca that could have delayed market competition to its flagship line of antipsychotic drugs were denied by the US Food and Drug Administration (FDA) on 9 March. AstraZeneca's Citizen Petitions requested that FDA delay market entry for generic products if those products omitted warnings about the risk of developing hyperglycemia. FDA required AstraZeneca to include such warnings on Seroquel and Seroquel XR (quetiapine ...

Australia's Therapeutic Goods Administration (TGA) said 2 March that it is working to establish "an ongoing collaboration in international inspection of [Active Pharmaceutical Ingredient (API)] manufacturers and [an] increase in the number of regulators participating" in their good manufacturing practice (GMP) pilot program. TGA noted that this collaboration has resulted in a governing document for the program, which will allow the World Health Organization to become a n...

A new bill introduced by Representative Brian Bilbray (R-CA) would rein in regulatory overlap by preventing states from "requiring duplicative inspections" of manufacturing plants. Bilbray's bill, the Science and Technology Regulatory Relief Act of 2012 (H.R. 4044) , prevents states from requiring US Food and Drug Administration-inspected manufacturers to undergo a state-sanctioned inspection. Exceptions are provided if the state receives complaints of unsafe produ...

Pharmaceutical manufacturer Warner Chilcott's attempt to delay generic competition for its Doryx acne pill has been rebuffed by the US Food and Drug Administration (FDA), according a response letter posted by the agency . Warner Chilcott had changed the scores on its Doryx tablets from one score to two scores. The scores are used by physicians and patients to properly split the pills. Warner Chilcott's change, it argued, was substantial enough that any generic manufactu...