Regulatory Affairs Professionals Society

Regulatory Affairs Professionals Society
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President Donald Trump’s budget sought a boost in funding for the US Food and Drug Administration (FDA) and now FDA Commissioner Scott Gottlieb is offering his own take on the initiatives and investments the agency plan to pursue. Plans outlined by Gottlieb include the creation of two new centers related to drug compounding and digital...

In the first-ever study using the US Food and Drug Administration's (FDA) Sentinel system by non-FDA stakeholders, a team of academic and industry researchers found that a 2010 label change for proton pump inhibitors (PPIs) led to less long-term use of the drugs. The study is also the second to be conducted using Sentinel to evaluate the impact of...

Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia. TGA Floats Changes to GMP Fees to Correct Historic Undercharging The Therapeutic Goods Administration (TGA) is planning to revise its good manufacturing practice (GMP) fees to correct historic undercharging. A Deloitte report found TGA’s fees failed to...

Johnson & Johnson (J&J) and Abbott, as well as industry groups PhRMA, BIO and AdvaMed have singled out their priorities related to the US Food and Drug Administration’s (FDA) call to modify, repeal or replace regulations, according to comments released Thursday on the docket. J&J compiled a list of seven priorities submitted to both CDER and CDRH,...

The US Food and Drug Administration (FDA) on Thursday unveiled another batch of new and revised product-specific draft guidances on, among other things, the design of bioequivalence (BE) studies to support abbreviated new drug applications (ANDAs). The 35 new and 22 revised guidance documents include what FDA said are 19 guidance documents on...

The UK's Medicines and Healthcare products Regulatory Agency (MHRA) and the China Food and Drug Administration (CFDA) on Wednesday signed a memorandum of understanding (MoU) to exchange information on new areas of drug and medical device regulation. The MoU was signed by MHRA Chief Ian Hudson and CFDA Director Bi Jingquan during UK Prime Minister...

This article provides an overview of critical regulatory requirements to be considered for Association of Southeast Nations (ASEAN) pharmaceutical markets and covers certificates of pharmaceutical products, regulatory submissions, pharmacopoeia, halal compliance, stability requirements, pharmacovigilance, product labeling, and drug variation...

Industry groups BIO, PhRMA and AAM, as well as AstraZeneca, Pfizer and Boehringer Ingelheim have offered comments on several proposed policy changes coming in 2019, and first announced in November by the Centers for Medicare & Medicaid Services (CMS). Nearly all of the commenters offered opinions on one of CMS’ requests for information pertaining...

New generic drug applications are not winning a lot of approvals from the US Food and Drug Administration (FDA) so far in January 2018, and at least part of the reason for an increase in complete response letters (CRLs) is a new requirement from the US Pharmacopeia (USP). Lachman Consultants' Bob Pollock, a former official in FDA’s Office of...

The five warning letters sent from the US Food and Drug Administration (FDA) in December and January and released this week deal with violations of current good manufacturing practice (cGMP) regulations for finished pharmaceuticals and active pharmaceutical ingredients (APIs). Shanwei Honghui Daily Appliance Following an FDA inspection of the...