FDA’s Office of Pharmaceutical Quality (OPQ) issued a new Manual of Policies and Procedures (MAPP) in June explaining the agency’s internal procedures for evaluating color additives and flavors in an oral drug product submitted as part of an investigational new drug application (IND), new drug application (NDA), and Type IV drug master file (DMF).
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Over the past year and as a result of the COVID-19 pandemic, FDA relied on alternative inspectional tools and approaches, including remote interactive evaluations and record requests, as well as a prioritization scheme, to continue its oversight activities.
As summarized in a July 17 LawFlash, FDA has resumed inspections of regulated domestic facilities using a new risk assessment rating system that takes into account the reopening phase of the applicable state, and county level COVID-19 statistics.
Our FDA lawyers discuss provisions in the Coronavirus Aid, Relief, and Economic Security (CARES) Act that are of particular concern and interest for the pharmaceutical, medical device, animal drug, and food industries, as well the potential effects of the stimulus package, in this recent LawFlash.
The FDA issued guidance on March 20 for the manufacture of hand sanitizers by companies not previously registered to make OTC drugs.
The FDA announced on March 18 that it is suspending onsite routine domestic inspections in an effort to slow the spread of the coronavirus (COVID-19) and help flatten the pandemic curve.
With the increasing numbers of coronavirus (COVID-19) cases and the declaration of a global pandemic by the World Health Organization, the pharmaceutical and biotech industries are assessing how this situation may impact business operations.
Now is the time for pharmaceutical manufacturers to review their Open Payments/Sunshine Act internal compliance procedures, data collection forms and databases, and reporting and recordkeeping templates for payments and transfers of value made to healthcare providers. On August 14, 2019, the Centers for Medicare and Medicaid Services (CMS) published a Proposed Rule seeking to expand the Open Payments program, including the number and types of covered recipients and payment categories.
President Donald Trump announced that, as of September 24, 2018, additional tariffs of 10% were imposed on hundreds of chemical ingredients, many of which are used in the manufacturing of dietary supplements, cosmetics, and over-the-counter (OTC) drug products.