Guidance Documents

New US FDA draft guidance attempts to address sponsor confusion about the different types of regulatory meetings under PDUFA, as well as frequently asked questions on nonclinical testing, CMC, pharm/tox and clinical studies.

Questions from researchers and public health advocates during workshop to discuss FDA authority under PREA Act point to agency and OTC NDA sponsors having additional boxes to check on potential unmet needs in drugs indicated for children and specifically on clarity of labeling for consumers of low health literacy, narrowing indications to prevent confusion and education about OTC drug formulations for health care providers.

Proposed administrative order likely is first to prompt opposition from OTC industry or other stakeholders potentially delaying or deferring the agency’s expectation for moving its proposal to a deemed final order effective one year after it would be published.

Trade group ready to work hand-in-hand with agency and other supplement industry stakeholders on potential regulatory changes or improvements, says president and CEO Steve Mister. “None of them are upsetting the basic balance of things that DSHEA was attempting to do, but there are things with 30 years that we've identified that need to be kind of fixed.”

While the firm’s mind and money continues to gear towards branded and novel drugs, India’s Sun Pharma still maintains a mammoth global generics business, including in the US where Sun saw a healthy leap in sales during its financial second quarter.

Supreme Court’s Loper Bright “decision is central to this case,” says Jonathan Emord, attorney representing Alliance for Natural Health USA and Meditrend Inc. in a complaint filed in US District Court for the District of Columbia.

Cell and gene therapy manufacturers based in Europe should speak to local regulators to understand how to demonstrate compliance with EU-level good manufacturing practice guidelines, as each country will apply the rules differently, an expert explains.

FDA’s OTC office director details a 2023 guidance as opening doors for NRT innovation at recent public meeting, but researchers and an industry executive note the most recent approval in the US for an innovative NRT was more than 20 years ago and say FDA isn’t allowing sufficient flexibility for approvals of new products or indications other than cessation related to quitting smoking.

FDA tobacco programs chief emphasizes moving smokers to lower risk alternatives and NIDA executive encourages proposals for e-cigarettes as nicotine replacement treatments. FDA also seizes $76m in unauthorized e-cigarettes.

The proposed new EU guidance will focus on the regulatory and methodological aspects of clinical trial design and marketing authorization for tRPs, according to a concept paper that has just been issued for public consultation.