USA – Stakeholders ask FDA to harmonize adverse events terms with standards orgs
Pharmaceutical companies are asking the US Food and Drug Administration (FDA) for more adverse events reporting standardization by harmonizing with standards organizations as well...
USA – Industry pushes FDA for tailored complex generics post-approval changes guidance
The US Food and Drug Administration (FDA) needs to develop guidance on post-approval changes for complex generics, and to update its guidance on post-approval...
USA – FDA takes first step to allow low-dose OTC naloxone on market
Low-dose naloxone drug products, including certain nasal sprays and autoinjectors, could one day be sold without a prescription, according to an initial assessment by...
USA – Biosimilar facilities usually get onsite inspections
A US Food and Drug Administration (FDA) official said that sites making biosimilars will be inspected in person, as opposed to virtual methods, as...
USA – FDA drafts guidance on ‘sameness’ evaluations for generic drugs
The US Food and Drug Administration (FDA) has released new draft guidance offering recommendations for applicants to prove sameness in active ingredients of abbreviated...
USA – FDA Says Face-to-Face Meetings Include Virtual
The FDA is changing its definition of face-to-face meetings to clarify that they include both in-person meetings and virtual meetings on audio- and video-enabled...
USA – FDA finalizes umbrella trial guidance for cell and gene therapies
The US Food and Drug Administration (FDA) laid out its recommendations for sponsors to study multiple versions of a cellular or gene therapy in...
USA – FDA updates guidance on expanded access for investigational drugs under IND
The US Food and Drug Administration (FDA) has updated its guidance for industry on expanded access to investigational drugs under an investigational new drug...
USA – FDA announces CMC review pilot for drugs with expedited development
The US Food and Drug Administration (FDA) announced on 31 October a limited chemistry, manufacturing and controls (CMC) development and readiness pilot (CDRP) program...
USA – FDA draft guidance aims to ensure accurate measurements of pediatric growth
Joint draft guidance from two centers at the US Food and Drug Administration (FDA) outlines ways sponsors can measure pediatric growth consistently in clinical...
