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The global personal care products industry is currently valued at USD 13.2 billion approximately and is expected to grow furthermore in the coming years. With the increase in numbers, the United States Senate has proposed a Personal Care Products Safety Act, a bill, to strengthen the regulations of ingredients of personal care products and protect consumer health.
In January 2006, the United States Food and Drug Administration (US FDA) introduced Structured Product Labeling (SPL) format for submitting product and facility information and changes to label submissions. The shift towards the new electronic format was aimed at uniformly informing patients, physicians, pharmacists, and the agency about the label content.
Every year, FDA regulates more than 190,000 medical devices pertaining to different classes. In order to provide better healthcare, the agency is striving continuously to update the pathways through which these devices are being submitted. In a recent press release, FDA announced that the agency is looking at the potential aspects to update the 510(k)-clearance pathway for medical devices.
In our earlier blog on US Food and Drug Administration’s (FDA) current thinking on post-approval changes, we discussed, what application types do the FDA’s industry guidance on post-approval changes to drug substances applies to and what types of changes does it emphasize.
Any modification to the drug substance manufacturing process such as facility / equipment changes, synthetic route changes etc. has the potential to affect the final drug product’s quality / efficacy / safety.
The United States Food and Drug Administration’s (USFDA’s) Pregnancy, Lactation and Labeling Rule (PLLR), which came into effect in June 2015, establishes a labeling standard for prescription drug products which can be used during maternity and lactation.
We are all aware, that the United States Food and Drug Administration (USFDA) has extended compliance date for Drug Master Files (DMFs) to be submitted in electronic Common Technical Document (eCTD) format, i.e., 5th May 2018.
About a year after issuing the final rule for antibacterial soaps, where it has banned 19 ingredients, the US Food and Drug Administration (FDA) has come out with an announcement on similar lines.
Are you deciding on when to submit a 510(k) for a change to an existing device? As we have reported earlier, the US Food and Drug Administration (FDA) has finalized the guidelines on changes in medical devices that would need a 510(K) submission.
The guidance is expected to aid manufacturers of:
The US Food and Drug Administration (FDA) has announced that it may release finalised guidelines for the device changes that would need a new 510(K) submission before 8th November, 2017.
North Africa & Middle East
Australia & New Zealand
Japan & South Korea
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