Is European Pharmacopeia compliance required for closure liners which may be used for pharmaceuticals in the EU?

What is the law regarding ingredient listing on bar soap packaging? If the ingredients are listed inside the packaging, do they also need to be...

In the skin care industry, an 'e' is sometimes used on a weight claim on a folding carton or container, such as 4.0 Fl. Oz. e 120 ml. What is the...

When repackaging OTC vitamins/supplements, do they have to be in a childproof container?

The U.S. Food and Drug Administration (FDA) has established a deadline after which all new drug applications (NDAs), abbreviated new drug applications (ANDAs), certain biologics license applications (BLAs), and certain investigational new drug applications (INDs) will need to be submitted electronically. Section 745A(a) of the Federal Food, Drug, and Cosmetic Act requires that certain drug and biologic submissions be submitted in electronic format within 24 or 36 months after FDA's issuance of final guidance on that topic.

Health Canada has increased Drug Master File (DMF) filing fees, effective as of April 1, 2015. The revised fee structure increases the cost of filing a new DMF to $424 (Canadian), the cost of filing a biannual update to $191 (Canadian), and the cost of filing a Letters of Access to $191 (Canadian).

The plastics industry and drug manufacturers have challenged India's proposed ban on the use of polyethylene terephthalate (PET) containers for primary drug packaging of liquid oral formulations for pediatric use, geriatric use, and for pregnant women and women of reproductive age.

Changes that are made to an approved New Drug Application (NDA) or Abbreviated New Drug Application (ANDA) are referred to as "post-approval" changes. All post-approval changes must be filed with the U.S. Food and Drug Administration (FDA) and are classified as major, moderate, or minor. The type of classification determines the type of documentation FDA requires for each notification. Major and moderate changes require supplemental filings and, depending on the severity of the change, may require FDA approval prior to market distribution.