Regulatory Oversight and Compliance

Weighing the pros and cons of REMS for bringing risky products to market.

Fallout escalates from McNeil recall and Genzyme shortages as regulators review oversight.

FDA chemistry reviewers in the Office of Generic Drugs provide an overview of common deficiences cited throughout the Chemistry, Manufacturing, and Controls section of ANDAs.

More information may be released to improve public understanding of regulatory policies.

The US Food and Drug Administration issued on June 25 a draft guidance for industry, "CMC Postapproval Manufacturing Changes Reportable in Annual Reports," to provide recommendations to drug applicants about the types of changes that may be included in annual reports.

Europe needs a more standardised and consistent approach for supplying excipient information to the regulators.

About one month after the announcement of McNeil Consumer Healthcare's recall of children's liquid pain and allergy medications , the US Food and Drug Administration testified before the US House Committee on Oversight and Government Reform about the issue.

Europe moves to place excipient GMP and GDP standards on the same level as active pharmaceutical ingredients.

Genzyme (Cambridge, MA) signed a consent decree of permanent injunction that requires the company to correct manufacturing-quality violations at its Allston, Massachusetts, manufacturing facility.

McNeil Consumer Healthcare is voluntarily recalling all lots that have not yet expired of certain over-the-counter children's and infants' liquid products.

Manufacturers will pay new fees but anticipate expanded drug use and safeguards for innovation.

New Draft Guidance for Solid Oral Dosage Forms Focuses on Physical Chemical Identifiers. This article is part of PharmTech's supplement "Solid Dosage and Excipients 2010."

FDA made available a draft guidance that would expand the information disclosed about conflict-of-interest waivers.

Genzyme provided an update on its manufacturing operations following the issuance of a draft consent decree by FDA regarding the company's Allston Landing, Massachusetts, manufacturing plant.

FDA Issues Warning Letter To Pfizer; And More.

FDA Issues Warning Letters to Six US Medical Spas; and More.

FDA lacks resources to manage expanding postmarketing responsibilities.

In an attempt to strengthen safeguards against counterfeit, diverted, subpotent, misbranded, adulterated, or expired drugs, FDA issued a new final guidance for industry.

Biotechnology company Genzyme reported that FDA notified the company that it intends to take enforcement action to ensure that products are made in compliance with good manufacturing practice (GMP) regulations.

FDA issued a new guidance for industry to help new drug applicants write the dosage and administration section of their products' labels.

The US Food and Drug Administration recently published guidance for the characterization and qualification of cell substrates, viral seeds, and other biological materials used to manufacture viral vaccines for human use.

FDA modernizes information systems, expands access to drug safety and use information.

FDA Releases Annual Guidance Agenda; OMB Urges Obama to Issue Revised Executive Order.

Vaccine R&D is surging, but continues to raise manufacturing and regulatory challenges.

Regulators and industry move to require inspections of API manufacturing facilities.

New York Governor Wants Stricter Limits On Pharmaceutical Marketing; And More.

Team leaders in FDA's Office of Generic Drugs provide an overview.

Generic-drug manufacturers look to expand into biologics and complex dosage forms. This article contains bonus online-exclusive material.

Also, FDA and WebMD increase collaboration and PPD is awarded contract to evaluate the agency's postmarket spontaneous-adverse-event surveillance system.

The heightened focus on risk raises concerns about delays in approving new drugs.