Unannounced facility visits also were to start again in China, but FDA Commissioner Robert Califf said they have been delayed by the COVID-19 outbreak in the country.

Drug approvals, clinical trials, pharmacovigilance and the use of unauthorized drugs are among areas targeted by draft legislation on a new therapeutic products scheme.

The EU regulator says it supports a globally aligned approach to the development of new antimicrobial medicines.

ERC Belgium has pledged to collect more data to convince the European Medicines Agency that Sitoiganap merits approval. Meanwhile, UGA Biopharma said it would address the agency’s objections over its biosimilar version of eptacog alfa.

The Philippines FDA is looking to leverage the work conducted by “stringent” regulators when it comes to reviewing certain clinical trial applications.

ANDA sponsors say eliminating the HFC propellant, while important to help address climate change, could upend the generic market without guidance from the US FDA.

De-centralized trials are way to help displaced Ukrainians remain in studies and could encourage greater participation from individuals in other countries, those overseeing sites in Ukraine say.

Committee Chair Maria Cantwell (D-Wash.) solicits advice from witnesses for additional authorities to conduct oversight of PBMs and pushes for a GAO study.

While Japan enters annual drug price revisions with frequent regulation changes, several major corporate players in the country warn again that government policies mean that the country is at risk of “losing attractiveness.”

The FDA’s principal deputy commissioner wonders how the agency will work with ARPA-H to help get its projects to patients and the health care system given its other responsibilities.

Regulators want to help smooth the process of bringing a gene therapy to market, hoping to iron out ‘surprises’ and even address reimbursement issues for the sake of patients.

International regulators have issued an updated statement on the benefits and safety of COVID-19 vaccines for use by health professionals, while the UK BioIndustry Association has welcomed a MAb licensing deal between AstraZeneca and UK-based biotech firm RQ Bio.

Regulators want to help smooth the process of bringing a gene therapy to market, hoping to iron out ‘surprises’ and even address reimbursement issues for the sake of patients.

New safety information may help defense of CMS's coverage restrictions. FDA updated the prescribing information for Biogen’s Alzheimer's therapy after four cases of seizures were reported in a trial.

Pfizer’s acquisition of Arena without FTC intervention and Hikma’s acquisition of Custopharm with one product divestiture shows the commission is bound by anticompetitive facts of a deal. A more controversial merger may not get through, former FTC attorney says.

Unannounced facility visits also were to start again in China, but FDA Commissioner Robert Califf said they have been delayed by the COVID-19 outbreak in the country.

Agency’s revised OOS guidance clarifies positions on outlier test results, averaging of HPLC results and some finer points around OOS questions. These could marginally improve compliance but won’t impact industry with nearly the force of the original 2006 guidance or the 1993 court ruling that preceded it.

Consultancy firms must have at least five years of experience in carrying out independent GMP or GDP audits if they want to apply to become a “compliance monitor” under a new MHRA scheme to keep track of drug companies that fail to comply with GMP/GDP requirements.